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It is an ideal-looking target, yet every drug against it has failed so far.","category":"Biomarkers"},{"id":"vein-to-vein-time","kind":"term","name":"Vein-to-vein time and manufacturing slots","route":"/terms/vein-to-vein-time/","tldr":"For CAR-T, the number of days from collecting the patient's cells to infusing the finished product, typically three to six weeks. Every day counts when the disease is aggressive, and manufacturing capacity (slots) limits how many patients can be treated.","category":"Treatment jargon"},{"id":"apheresis","kind":"term","name":"Apheresis (leukapheresis)","route":"/terms/apheresis/","tldr":"Running a patient's blood through a machine that skims off one type of cell (T cells, or stem cells) and returns the rest; the harvested cells become the raw material for CAR-T or a transplant.","category":"Procedures"}],"engine":{"route":"/pipeline/engine/car-t/","axes":["Target","Costimulatory domain"],"rows":13,"cols":2,"counts":{"approved":5,"development":11,"stopped":0,"unclear":0,"untried":23},"placed":35,"total":36,"pct":97},"approved":[{"drug":{"id":"axicabtagene-ciloleucel","kind":"drug","name":"Axicabtagene ciloleucel","route":"/drugs/axicabtagene-ciloleucel/"},"brand":"Yescarta","status":"approved","modality":"CAR-T (CD19)","cancers":[{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"},{"id":"primary-mediastinal-b-cell-lymphoma","kind":"cancer","name":"Primary mediastinal (thymic) large B-cell lymphoma","route":"/cancers/primary-mediastinal-b-cell-lymphoma/"}],"indications":["Relapsed/refractory large B-cell lymphoma ≥2 lines","Second-line LBCL refractory or relapsed within 12 months"],"years":[2017,2022],"firstYear":2017,"regions":["US"],"target":{"key":"target","id":"cd19","name":"CD19","href":"/targets/cd19/"},"companies":[{"id":"gilead","kind":"company","name":"Gilead Sciences (incl. 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ciloleucel","route":"/drugs/axicabtagene-ciloleucel/"},{"id":"ciltacabtagene-autoleucel","kind":"drug","name":"Ciltacabtagene autoleucel","route":"/drugs/ciltacabtagene-autoleucel/"},{"id":"tisagenlecleucel","kind":"drug","name":"Tisagenlecleucel","route":"/drugs/tisagenlecleucel/"}]},{"group":"Low white cells (neutropenia)","drugs":3,"maxGrade3":96,"examples":[{"id":"ciltacabtagene-autoleucel","kind":"drug","name":"Ciltacabtagene autoleucel","route":"/drugs/ciltacabtagene-autoleucel/"},{"id":"idecabtagene-vicleucel","kind":"drug","name":"Idecabtagene vicleucel","route":"/drugs/idecabtagene-vicleucel/"},{"id":"talicabtagene-autoleucel","kind":"drug","name":"Talicabtagene autoleucel","route":"/drugs/talicabtagene-autoleucel/"}]},{"group":"Low platelets (thrombocytopenia)","drugs":1,"maxGrade3":65,"examples":[{"id":"talicabtagene-autoleucel","kind":"drug","name":"Talicabtagene autoleucel","route":"/drugs/talicabtagene-autoleucel/"}]},{"group":"Low red cells (anaemia)","drugs":1,"maxGrade3":61,"examples":[{"id":"talicabtagene-autoleucel","kind":"drug","name":"Talicabtagene autoleucel","route":"/drugs/talicabtagene-autoleucel/"}]},{"group":"Nausea or vomiting","drugs":1,"examples":[{"id":"satricabtagene-autoleucel","kind":"drug","name":"Satricabtagene autoleucel","route":"/drugs/satricabtagene-autoleucel/"}]},{"group":"Second cancers","drugs":1,"maxAnyGrade":3,"examples":[{"id":"ciltacabtagene-autoleucel","kind":"drug","name":"Ciltacabtagene autoleucel","route":"/drugs/ciltacabtagene-autoleucel/"}]}],"drugsWithToxicity":8},"resistance":[{"id":"bcma-directed","drugClass":"BCMA-directed therapy (CAR-T, bispecifics, ADC)","tldr":"Myeloma escapes BCMA drugs by deleting or mutating the target, or by exhausting the T cells that were supposed to do the killing.","route":"/resistance/#bcma-directed","exemplars":[{"id":"ciltacabtagene-autoleucel","kind":"drug","name":"Ciltacabtagene autoleucel","route":"/drugs/ciltacabtagene-autoleucel/"},{"id":"teclistamab","kind":"drug","name":"Teclistamab","route":"/drugs/teclistamab/"},{"id":"belantamab-mafodotin","kind":"drug","name":"Belantamab mafodotin","route":"/drugs/belantamab-mafodotin/"}],"mechanisms":[{"name":"BCMA antigen loss (biallelic TNFRSF17 deletion, extracellular mutations)","category":"antigen","categoryLabel":"Antigen loss","how":"Deletion or mutation removes or alters the epitope; more common after bispecifics than CAR-T.","frequency":"~10 to 30% after bispecifics","route":"/resistance/#bcma-directed-bcma-antigen-loss-biallelic-tnfrsf17-deletion-extracellular-mutations"},{"name":"T-cell exhaustion and low fitness","category":"immune-evasion","categoryLabel":"Immune evasion","how":"Prior lines, high tumour burden, and continuous bispecific dosing exhaust T cells; CAR-T products from heavily pretreated patients expand poorly.","route":"/resistance/#bcma-directed-t-cell-exhaustion-and-low-fitness"},{"name":"Soluble BCMA decoy","category":"pharmacology","categoryLabel":"Pharmacology","how":"Shed BCMA binds drug in circulation.","route":"/resistance/#bcma-directed-soluble-bcma-decoy"}],"sources":[{"label":"CARTITUDE-4 (NEJM 2023)","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2303379"}]},{"id":"cd19-car-t","drugClass":"CD19 CAR-T","tldr":"Leukaemia and lymphoma relapse after CD19 CAR-T either without CD19 (the target is gone) or with it (the CAR-T cells are gone or exhausted).","route":"/resistance/#cd19-car-t","exemplars":[{"id":"axicabtagene-ciloleucel","kind":"drug","name":"Axicabtagene ciloleucel","route":"/drugs/axicabtagene-ciloleucel/"},{"id":"blinatumomab","kind":"drug","name":"Blinatumomab","route":"/drugs/blinatumomab/"}],"mechanisms":[{"name":"CD19-negative relapse","category":"antigen","categoryLabel":"Antigen loss","how":"Alternative splicing, mutation, or lineage switch (to myeloid) removes the CD19 epitope.","frequency":"~30 to 50% of relapses in ALL, less in lymphoma","route":"/resistance/#cd19-car-t-cd19-negative-relapse"},{"name":"CD19-positive relapse from poor CAR-T persistence","category":"pharmacology","categoryLabel":"Pharmacology","how":"Limited expansion or early loss of CAR-T cells; 4-1BB products persist longer than CD28.","route":"/resistance/#cd19-car-t-cd19-positive-relapse-from-poor-car-t-persistence"},{"name":"Immunosuppressive microenvironment and T-cell exhaustion","category":"immune-evasion","categoryLabel":"Immune evasion","how":"PD-1 upregulation, TGF-β, and myeloid suppression in lymphoma.","route":"/resistance/#cd19-car-t-immunosuppressive-microenvironment-and-t-cell-exhaustion"}],"sources":[{"label":"ZUMA-7 OS (NEJM 2023)","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2301665"}]}],"papers":[{"id":"paper-ct041-st-01-lancet-2025","kind":"paper","name":"Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) versus treatment of physician's choice for previously treated advanced gastric or gastro-oesophageal junction cancer (CT041-ST-01): a randomised, open-label, phase 2 trial","route":"/key-papers/paper-ct041-st-01-lancet-2025/","year":2025,"journal":"The Lancet","paperType":"rct","tldr":"The first randomised trial of CAR-T cells in a solid tumour: in heavily pretreated Claudin 18.2-positive stomach cancer, satri-cel held the disease for a median of 3.25 months against 1.77 months on the doctor's choice of drug, with almost universal cytokine release syndrome.","via":[{"id":"satricabtagene-autoleucel","kind":"drug","name":"Satricabtagene autoleucel","route":"/drugs/satricabtagene-autoleucel/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"paper-chen-exp-hematol-oncol","kind":"paper","name":"Phase II study of zevorcabtagene autoleucel, a fully human BCMA-targeting CAR T cell therapy, in patients with relapsed/refractory multiple myeloma","route":"/key-papers/paper-chen-exp-hematol-oncol/","year":2025,"journal":"Experimental hematology & oncology","paperType":"observational","tldr":"Paper cited by one trial page and one treatment page, indexed on Europe PMC as PubMed record 41029877 and published in Experimental hematology & oncology; the citing pages link this DOI, which is how the record was matched.","via":[{"id":"zevorcabtagene-autoleucel","kind":"drug","name":"Zevorcabtagene autoleucel","route":"/drugs/zevorcabtagene-autoleucel/"}]},{"id":"paper-jain-talicabtagene-lancet-haem-2025","kind":"paper","name":"Talicabtagene autoleucel for relapsed or refractory B-cell malignancies: an open-label, multicentre, phase 1/2 study","route":"/key-papers/paper-jain-talicabtagene-lancet-haem-2025/","year":2025,"journal":"Lancet Haematology","paperType":"rct","tldr":"The trial report behind India's first CAR-T therapy: about three in four heavily pretreated patients with lymphoma or leukaemia responded to cells engineered and made in Mumbai.","via":[{"id":"talicabtagene-autoleucel","kind":"drug","name":"Talicabtagene autoleucel","route":"/drugs/talicabtagene-autoleucel/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"paper-li-jama-oncol","kind":"paper","name":"Equecabtagene Autoleucel in Patients With Relapsed or Refractory Multiple Myeloma: The FUMANBA-1 Nonrandomized Clinical Trial","route":"/key-papers/paper-li-jama-oncol/","year":2024,"journal":"JAMA Oncology","paperType":"observational","tldr":"Paper cited by one trial page and one treatment page, indexed on Europe PMC as PubMed record 39509090 and published in JAMA Oncology; the citing pages link this DOI, which is how the record was matched.","via":[{"id":"equecabtagene-autoleucel","kind":"drug","name":"Equecabtagene autoleucel","route":"/drugs/equecabtagene-autoleucel/"}]},{"id":"paper-martinez-cibrian-br-j-haematol","kind":"paper","name":"The academic point-of-care anti-CD19 chimeric antigen receptor T-cell product varnimcabtagene autoleucel (ARI-0001 cells) shows efficacy and safety in the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma","route":"/key-papers/paper-martinez-cibrian-br-j-haematol/","year":2024,"journal":"British journal of haematology","paperType":"observational","tldr":"Paper cited by one treatment page, indexed on Europe PMC as PubMed record 37905734 and published in British journal of haematology; the citing page links this DOI, which is how the record was matched.","via":[{"id":"varnimcabtagene-autoleucel","kind":"drug","name":"Varnimcabtagene autoleucel","route":"/drugs/varnimcabtagene-autoleucel/"}]},{"id":"paper-dhillon-mol-diagn-ther","kind":"paper","name":"Zevorcabtagene Autoleucel: First Approval","route":"/key-papers/paper-dhillon-mol-diagn-ther/","year":2024,"journal":"Molecular diagnosis & therapy","paperType":"review","tldr":"Paper cited by one treatment page, indexed on Europe PMC as PubMed record 38888762 and published in Molecular diagnosis & therapy; the citing page links this DOI, which is how the record was matched.","via":[{"id":"zevorcabtagene-autoleucel","kind":"drug","name":"Zevorcabtagene autoleucel","route":"/drugs/zevorcabtagene-autoleucel/"}]},{"id":"paper-cartitude-4-cilta-cel-nejm-2023","kind":"paper","name":"CARTITUDE-4: cilta-cel CAR-T versus standard combinations after one to three prior lines of myeloma therapy","route":"/key-papers/paper-cartitude-4-cilta-cel-nejm-2023/","year":2023,"journal":"New England Journal of Medicine","paperType":"rct","tldr":"Moving BCMA CAR-T to the second line cut the risk of progression or death by 74% compared with standard triplets, and later improved overall survival.","via":[{"id":"ciltacabtagene-autoleucel","kind":"drug","name":"Ciltacabtagene autoleucel","route":"/drugs/ciltacabtagene-autoleucel/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"paper-nxc-201-hbi0101-asherie-haematologica-2023","kind":"paper","name":"Development and manufacture of novel locally produced anti-BCMA CAR T cells for the treatment of relapsed/refractory multiple myeloma: results from a phase I clinical trial (HBI0101)","route":"/key-papers/paper-nxc-201-hbi0101-asherie-haematologica-2023/","year":2023,"journal":"Haematologica","paperType":"observational","tldr":"A hospital in Jerusalem built and made its own CAR-T cells against the myeloma protein BCMA; in the first 20 heavily treated patients, 75 percent responded and half went into complete remission, with only mild immune reactions.","via":[{"id":"nxc-201-car-t","kind":"drug","name":"NXC-201 CAR-T","route":"/drugs/nxc-201-car-t/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"paper-keam-mol-diagn-ther","kind":"paper","name":"Equecabtagene Autoleucel: First Approval","route":"/key-papers/paper-keam-mol-diagn-ther/","year":2023,"journal":"Molecular diagnosis & therapy","paperType":"review","tldr":"Paper cited by one treatment page, indexed on Europe PMC as PubMed record 37658205 and published in Molecular diagnosis & therapy; the citing page links this DOI, which is how the record was matched.","via":[{"id":"equecabtagene-autoleucel","kind":"drug","name":"Equecabtagene autoleucel","route":"/drugs/equecabtagene-autoleucel/"}]},{"id":"paper-karmma-3-ide-cel-nejm-2023","kind":"paper","name":"KarMMa-3: ide-cel CAR-T versus standard regimens in triple-class-exposed relapsed myeloma","route":"/key-papers/paper-karmma-3-ide-cel-nejm-2023/","year":2023,"journal":"New England Journal of Medicine","paperType":"rct","tldr":"The first randomised CAR-T trial in myeloma tripled median progression-free survival (13.3 versus 4.4 months) compared with standard combinations after two to four prior lines.","via":[{"id":"idecabtagene-vicleucel","kind":"drug","name":"Idecabtagene vicleucel","route":"/drugs/idecabtagene-vicleucel/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"paper-majzner-nature","kind":"paper","name":"GD2-CAR T cell therapy for H3K27M-mutated diffuse midline gliomas","route":"/key-papers/paper-majzner-nature/","year":2022,"journal":"Nature","paperType":"basic","tldr":"Paper cited by one cancer page and one technology page, indexed on Europe PMC as PubMed record 35130560 and published in Nature; the citing pages link this DOI, which is how the record was matched.","via":[{"id":"glioma-car-t","kind":"technology","name":"CAR-T for glioma (IL13Rα2, GD2, EGFRvIII, multi-target)","route":"/technologies/glioma-car-t/"}]},{"id":"paper-transform-liso-cel-lancet-2022","kind":"paper","name":"TRANSFORM: liso-cel CAR-T versus salvage chemotherapy and transplant in early-relapsing large B-cell lymphoma","route":"/key-papers/paper-transform-liso-cel-lancet-2022/","year":2022,"journal":"The Lancet","paperType":"rct","tldr":"In TRANSFORM, a second CD19 CAR-T, lisocabtagene maraleucel, also beat chemotherapy-plus-transplant as second-line treatment, with a low rate of severe side effects.","via":[{"id":"lisocabtagene-maraleucel","kind":"drug","name":"Lisocabtagene maraleucel","route":"/drugs/lisocabtagene-maraleucel/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"paper-zuma-7-axi-cel-second-line-nejm-2022","kind":"paper","name":"ZUMA-7: axi-cel CAR-T instead of salvage chemotherapy and transplant for large B-cell lymphoma that relapses early","route":"/key-papers/paper-zuma-7-axi-cel-second-line-nejm-2022/","year":2022,"journal":"New England Journal of Medicine","paperType":"rct","tldr":"For lymphoma that came back within a year, going straight to CAR-T beat the decades-old chemotherapy-then-transplant approach, and later improved survival.","via":[{"id":"axicabtagene-ciloleucel","kind":"drug","name":"Axicabtagene ciloleucel","route":"/drugs/axicabtagene-ciloleucel/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"paper-cartitude-1-cilta-cel-lancet-2021","kind":"paper","name":"CARTITUDE-1: cilta-cel, a BCMA CAR-T, in heavily pretreated myeloma","route":"/key-papers/paper-cartitude-1-cilta-cel-lancet-2021/","year":2021,"journal":"The Lancet","paperType":"translational","tldr":"A single infusion of BCMA-directed CAR-T cells produced responses in 97% of patients whose myeloma had failed a median of six prior lines, with two-thirds reaching stringent complete response.","via":[{"id":"ciltacabtagene-autoleucel","kind":"drug","name":"Ciltacabtagene autoleucel","route":"/drugs/ciltacabtagene-autoleucel/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"paper-destiny-crc01-lancet-oncol-2021","kind":"paper","name":"DESTINY-CRC01: trastuzumab deruxtecan in HER2-expressing metastatic colorectal cancer","route":"/key-papers/paper-destiny-crc01-lancet-oncol-2021/","year":2021,"journal":"The Lancet Oncology","paperType":"observational","tldr":"Trastuzumab deruxtecan shrank tumours in about 45 percent of patients with HER2-high colorectal cancer, including those who had already received other HER2 drugs, but did nothing for tumours with low HER2 expression and carried a risk of lung inflammation.","via":[{"id":"crc01","kind":"drug","name":"CRC01","route":"/drugs/crc01/"}]},{"id":"paper-ying-cancer-med","kind":"paper","name":"Relmacabtagene autoleucel (relma-cel) CD19 CAR-T therapy for adults with heavily pretreated relapsed/refractory large B-cell lymphoma in China","route":"/key-papers/paper-ying-cancer-med/","year":2021,"journal":"Cancer medicine","paperType":"rct","tldr":"Paper cited by one trial page and one treatment page, indexed on Europe PMC as PubMed record 33382529 and published in Cancer medicine; the citing pages link this DOI, which is how the record was matched.","via":[{"id":"relmacabtagene-autoleucel","kind":"drug","name":"Relmacabtagene autoleucel","route":"/drugs/relmacabtagene-autoleucel/"}]},{"id":"paper-klichinsky-nat-biotechnol","kind":"paper","name":"Human chimeric antigen receptor macrophages for cancer immunotherapy","route":"/key-papers/paper-klichinsky-nat-biotechnol/","year":2020,"journal":"Nature Biotechnology","paperType":"basic","tldr":"Paper cited by one technology page, indexed on Europe PMC as PubMed record 32361713 and published in Nature Biotechnology; the citing page links this DOI, which is how the record was matched.","via":[{"id":"car-nk-macrophage","kind":"technology","name":"CAR-NK & CAR-macrophage","route":"/technologies/car-nk-macrophage/"}]},{"id":"paper-ucart19-allogeneic-car-t-lancet-2020","kind":"paper","name":"UCART19: the first gene-edited, donor-derived CAR-T cells in children and adults with relapsed B-cell ALL","route":"/key-papers/paper-ucart19-allogeneic-car-t-lancet-2020/","year":2020,"journal":"The Lancet","paperType":"translational","tldr":"Off-the-shelf CAR-T cells made from a healthy donor, gene-edited to avoid rejection and graft-versus-host disease, produced remission in 14 of 21 patients with relapsed ALL.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"},{"id":"in-vivo-car-t","kind":"technology","name":"In vivo CAR-T","route":"/technologies/in-vivo-car-t/"},{"id":"point-of-care-cell-manufacturing","kind":"technology","name":"Point-of-care and decentralised cell manufacturing","route":"/technologies/point-of-care-cell-manufacturing/"}]},{"id":"paper-liu-n-engl-j-med","kind":"paper","name":"Use of CAR-Transduced Natural Killer Cells in CD19-Positive Lymphoid Tumors","route":"/key-papers/paper-liu-n-engl-j-med/","year":2020,"journal":"New England Journal of Medicine","paperType":"observational","tldr":"Paper cited by one technology page, indexed on Europe PMC as PubMed record 32023374 and published in New England Journal of Medicine; the citing page links this DOI, which is how the record was matched.","via":[{"id":"car-nk-macrophage","kind":"technology","name":"CAR-NK & CAR-macrophage","route":"/technologies/car-nk-macrophage/"}]},{"id":"paper-zuma-2-brexu-cel-mantle-cell-nejm-2020","kind":"paper","name":"ZUMA-2: brexu-cel CAR-T for mantle cell lymphoma that has failed BTK inhibitors","route":"/key-papers/paper-zuma-2-brexu-cel-mantle-cell-nejm-2020/","year":2020,"journal":"New England Journal of Medicine","paperType":"translational","tldr":"In mantle cell lymphoma that had stopped responding to BTK inhibitors, a single CAR-T infusion produced responses in 93% of patients and complete remissions in two-thirds.","via":[{"id":"brexucabtagene-autoleucel","kind":"drug","name":"Brexucabtagene autoleucel","route":"/drugs/brexucabtagene-autoleucel/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"paper-juliet-tisagenlecleucel-dlbcl-nejm-2019","kind":"paper","name":"JULIET: tisagenlecleucel for adults with relapsed or refractory diffuse large B-cell lymphoma","route":"/key-papers/paper-juliet-tisagenlecleucel-dlbcl-nejm-2019/","year":2019,"journal":"New England Journal of Medicine","paperType":"translational","tldr":"In adults with aggressive lymphoma after at least two prior treatments, tisagenlecleucel produced responses in 52% and complete responses in 40%, most of which lasted.","via":[{"id":"tisagenlecleucel","kind":"drug","name":"Tisagenlecleucel","route":"/drugs/tisagenlecleucel/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"paper-eliana-tisagenlecleucel-nejm-2018","kind":"paper","name":"ELIANA: the global trial that made tisagenlecleucel the first approved CAR-T therapy for children and young adults with relapsed ALL","route":"/key-papers/paper-eliana-tisagenlecleucel-nejm-2018/","year":2018,"journal":"New England Journal of Medicine","paperType":"translational","tldr":"Across 25 centres, 81% of children and young adults with relapsed or refractory ALL went into remission after a single tisagenlecleucel infusion, and half were still event-free a year later.","via":[{"id":"obecabtagene-autoleucel","kind":"drug","name":"Obecabtagene autoleucel","route":"/drugs/obecabtagene-autoleucel/"},{"id":"tisagenlecleucel","kind":"drug","name":"Tisagenlecleucel","route":"/drugs/tisagenlecleucel/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"},{"id":"apheresis-starting-material","kind":"technology","name":"Apheresis and starting-material collection","route":"/technologies/apheresis-starting-material/"}]},{"id":"paper-pfeiffer-embo-mol-med","kind":"paper","name":"In vivo generation of human CD19-CAR T cells results in B-cell depletion and signs of cytokine release syndrome","route":"/key-papers/paper-pfeiffer-embo-mol-med/","year":2018,"journal":"EMBO molecular medicine","paperType":"basic","tldr":"Paper cited by one technology page and one idea page, indexed on Europe PMC as PubMed record 30224381 and published in EMBO molecular medicine; the citing pages link this DOI, which is how the record was matched.","via":[{"id":"in-vivo-car-t","kind":"technology","name":"In vivo CAR-T","route":"/technologies/in-vivo-car-t/"}]},{"id":"paper-zuma-1-axi-cel-nejm-2017","kind":"paper","name":"ZUMA-1: axicabtagene ciloleucel for refractory large B-cell lymphoma, the first CAR-T approved for lymphoma","route":"/key-papers/paper-zuma-1-axi-cel-nejm-2017/","year":2017,"journal":"New England Journal of Medicine","paperType":"translational","tldr":"In lymphoma refractory to chemotherapy, where expected survival was around six months, a single CAR-T infusion produced responses in 82% of patients and long-term remission in about 40%.","via":[{"id":"axicabtagene-ciloleucel","kind":"drug","name":"Axicabtagene ciloleucel","route":"/drugs/axicabtagene-ciloleucel/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"paper-brown-n-engl-j-med","kind":"paper","name":"Regression of Glioblastoma after Chimeric Antigen Receptor T-Cell Therapy","route":"/key-papers/paper-brown-n-engl-j-med/","year":2016,"journal":"New England Journal of Medicine","paperType":"observational","tldr":"Paper cited by one technology page, indexed on Europe PMC as PubMed record 28029927 and published in New England Journal of Medicine; the citing page links this DOI, which is how the record was matched.","via":[{"id":"glioma-car-t","kind":"technology","name":"CAR-T for glioma (IL13Rα2, GD2, EGFRvIII, multi-target)","route":"/technologies/glioma-car-t/"}]},{"id":"paper-maude-ctl019-all-nejm-2014","kind":"paper","name":"Maude 2014: CD19 CAR-T cells produce complete remission in 27 of 30 children and adults with relapsed ALL","route":"/key-papers/paper-maude-ctl019-all-nejm-2014/","year":2014,"journal":"New England Journal of Medicine","paperType":"translational","tldr":"The first sizeable series of CD19 CAR-T therapy showed complete remission in 90% of patients with leukaemia that had failed everything else, with persistent engineered cells and a new, treatable toxicity.","via":[{"id":"tisagenlecleucel","kind":"drug","name":"Tisagenlecleucel","route":"/drugs/tisagenlecleucel/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]}],"eras":[{"roadmap":{"id":"cell-therapy-roadmap","kind":"roadmap","name":"Cell therapy roadmap: CD19 CAR-T → solid tumours → in vivo CAR","route":"/roadmaps/cell-therapy-roadmap/"},"era":"2017-2022","title":"CD19 and BCMA CAR-T approved","status":"historic","step":2,"route":"/roadmaps/cell-therapy-roadmap/#story-step-1","refs":[{"id":"axicabtagene-ciloleucel","kind":"drug","name":"Axicabtagene ciloleucel","route":"/drugs/axicabtagene-ciloleucel/"},{"id":"ciltacabtagene-autoleucel","kind":"drug","name":"Ciltacabtagene autoleucel","route":"/drugs/ciltacabtagene-autoleucel/"}]},{"roadmap":{"id":"cell-therapy-roadmap","kind":"roadmap","name":"Cell therapy roadmap: CD19 CAR-T → solid tumours → in vivo CAR","route":"/roadmaps/cell-therapy-roadmap/"},"era":"2024-2026","title":"Solid tumours: TIL, TCR-T, CAR-T","status":"current","step":3,"route":"/roadmaps/cell-therapy-roadmap/#story-step-2","refs":[{"id":"satricabtagene-autoleucel","kind":"drug","name":"Satricabtagene autoleucel","route":"/drugs/satricabtagene-autoleucel/"}]},{"roadmap":{"id":"cell-therapy-roadmap","kind":"roadmap","name":"Cell therapy roadmap: CD19 CAR-T → solid tumours → in vivo CAR","route":"/roadmaps/cell-therapy-roadmap/"},"era":"2025-2028","title":"Manufacturing revolution: allogeneic and in vivo","status":"emerging","step":4,"route":"/roadmaps/cell-therapy-roadmap/#story-step-3","refs":[{"id":"in-vivo-car-t","kind":"technology","name":"In vivo CAR-T","route":"/technologies/in-vivo-car-t/"},{"id":"car-nk-macrophage","kind":"technology","name":"CAR-NK & CAR-macrophage","route":"/technologies/car-nk-macrophage/"}]},{"roadmap":{"id":"global-access-roadmap","kind":"roadmap","name":"Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation","route":"/roadmaps/global-access-roadmap/"},"era":"2018-2026","title":"Homegrown innovation in India and China","status":"current","step":4,"route":"/roadmaps/global-access-roadmap/#story-step-3","refs":[{"id":"talicabtagene-autoleucel","kind":"drug","name":"Talicabtagene autoleucel","route":"/drugs/talicabtagene-autoleucel/"},{"id":"varnimcabtagene-autoleucel","kind":"drug","name":"Varnimcabtagene autoleucel","route":"/drugs/varnimcabtagene-autoleucel/"},{"id":"relmacabtagene-autoleucel","kind":"drug","name":"Relmacabtagene autoleucel","route":"/drugs/relmacabtagene-autoleucel/"}]},{"roadmap":{"id":"immunotherapy-roadmap","kind":"roadmap","name":"Immunotherapy roadmap: Coley's toxins → checkpoint inhibitors → engineered immunity","route":"/roadmaps/immunotherapy-roadmap/"},"era":"2024-2027","title":"Engineered immunity arrives","status":"emerging","step":4,"route":"/roadmaps/immunotherapy-roadmap/#story-step-3","refs":[{"id":"in-vivo-car-t","kind":"technology","name":"In vivo CAR-T","route":"/technologies/in-vivo-car-t/"}]},{"roadmap":{"id":"paediatric-oncology-roadmap","kind":"roadmap","name":"Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first","route":"/roadmaps/paediatric-oncology-roadmap/"},"era":"2014-2026","title":"Engineered immunity, children first","status":"current","step":3,"route":"/roadmaps/paediatric-oncology-roadmap/#story-step-2","refs":[{"id":"tisagenlecleucel","kind":"drug","name":"Tisagenlecleucel","route":"/drugs/tisagenlecleucel/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"},{"id":"glioma-car-t","kind":"technology","name":"CAR-T for glioma (IL13Rα2, GD2, EGFRvIII, multi-target)","route":"/technologies/glioma-car-t/"}]},{"roadmap":{"id":"paediatric-oncology-roadmap","kind":"roadmap","name":"Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first","route":"/roadmaps/paediatric-oncology-roadmap/"},"era":"2026-2030","title":"Next trials, next targets, one global plan","status":"emerging","step":6,"route":"/roadmaps/paediatric-oncology-roadmap/#story-step-5","refs":[{"id":"glioma-car-t","kind":"technology","name":"CAR-T for glioma (IL13Rα2, GD2, EGFRvIII, multi-target)","route":"/technologies/glioma-car-t/"}]},{"roadmap":{"id":"cure-paths","kind":"roadmap","name":"Paths to cures: interception, eradication, control","route":"/roadmaps/cure-paths/"},"era":"Eradication: established","title":"Removing every cell, and knowing that you did","status":"current","step":3,"route":"/roadmaps/cure-paths/#story-step-2","refs":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"roadmap":{"id":"frontier-2035","kind":"roadmap","name":"Radical oncology: what could change the war by 2035","route":"/roadmaps/frontier-2035/"},"era":"By 2035 (attacking the host, not the tumour)","title":"Treating the soil rather than the seed","status":"speculative","step":6,"route":"/roadmaps/frontier-2035/#story-step-5","refs":[{"id":"stroma-directed-car","kind":"technology","name":"CAR-T against stroma: fibroblasts and myeloid cells","route":"/technologies/stroma-directed-car/"}]}],"ideas":[{"id":"idea-reg-cart-outcomes-refund","kind":"idea","name":"Full refund for CAR-T if the patient has not responded at three months","route":"/ideas/idea-reg-cart-outcomes-refund/","maturity":"being-tested-at-scale","tldr":"Health systems would pay for a $400,000 cell therapy only if it works. If the cancer has not responded by three months, the company refunds the price.","via":[{"id":"axicabtagene-ciloleucel","kind":"drug","name":"Axicabtagene ciloleucel","route":"/drugs/axicabtagene-ciloleucel/"},{"id":"ciltacabtagene-autoleucel","kind":"drug","name":"Ciltacabtagene autoleucel","route":"/drugs/ciltacabtagene-autoleucel/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-car-t-replaces-transplant","kind":"idea","name":"One CAR-T infusion instead of autologous transplant","route":"/ideas/idea-car-t-replaces-transplant/","maturity":"being-tested-at-scale","tldr":"Replace high-dose melphalan and stem-cell rescue with a single infusion of the patient's engineered T cells after induction.","via":[{"id":"ciltacabtagene-autoleucel","kind":"drug","name":"Ciltacabtagene autoleucel","route":"/drugs/ciltacabtagene-autoleucel/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-cd30-car-t-hodgkin","kind":"idea","name":"CD30 CAR-T for multiply relapsed Hodgkin lymphoma","route":"/ideas/idea-cd30-car-t-hodgkin/","maturity":"early-clinical","tldr":"Engineer T cells against CD30 for the few patients who fail brentuximab, PD-1 blockade and transplant.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-reg-early-apheresis-banking","kind":"idea","name":"Collect and freeze T cells at diagnosis for high-risk patients, before chemotherapy","route":"/ideas/idea-reg-early-apheresis-banking/","maturity":"early-clinical","tldr":"By the time patients need CAR-T their immune cells are often exhausted by earlier treatment. Storing healthy cells early would improve manufacturing success and cut the wait.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-bio2-intraventricular-car-t","kind":"idea","name":"Deliver CAR-T cells straight into the fluid around the brain","route":"/ideas/idea-bio2-intraventricular-car-t/","maturity":"early-clinical","tldr":"Cancer spreading along the linings of the brain is almost untreatable. Injecting engineered immune cells directly into the brain fluid, through a small reservoir, reaches it.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"},{"id":"glioma-car-t","kind":"technology","name":"CAR-T for glioma (IL13Rα2, GD2, EGFRvIII, multi-target)","route":"/technologies/glioma-car-t/"}]},{"id":"idea-gd2-car-t-frontline-consolidation","kind":"idea","name":"GD2 CAR-T as consolidation in high-risk neuroblastoma","route":"/ideas/idea-gd2-car-t-frontline-consolidation/","maturity":"early-clinical","tldr":"Give engineered GD2 T cells to children in remission after standard therapy, where the long-term data show the deepest and longest cures.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-reg-hospital-exemption-harmonised","kind":"idea","name":"Harmonise Europe's hospital exemption for academic cell therapies, with one registry","route":"/ideas/idea-reg-hospital-exemption-harmonised/","maturity":"early-clinical","tldr":"Spain lets hospitals make and use their own CAR-T under a special rule; most European countries do not. A common rule with shared outcome tracking would spread affordable academic products.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-fund-public-car-t-manufacturing","kind":"idea","name":"Hospital-based CAR-T manufacturing at cost through a public network","route":"/ideas/idea-fund-public-car-t-manufacturing/","maturity":"early-clinical","tldr":"Academic hospitals can already make CAR-T cells for a fraction of the commercial price. A public network would scale that so more patients can be treated for less.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-fund-hospital-exemption-registry","kind":"idea","name":"Hospital-exemption cell therapies at scale, backed by a shared registry","route":"/ideas/idea-fund-hospital-exemption-registry/","maturity":"early-clinical","tldr":"European law already lets hospitals make advanced therapies for their own patients. Pair that with a shared outcomes registry so academic CAR-Ts and similar treatments can prove themselves without a commercial licence.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-reg-point-of-care-cart-network","kind":"idea","name":"Hospital-made CAR-T under one shared regulatory master file","route":"/ideas/idea-reg-point-of-care-cart-network/","maturity":"early-clinical","tldr":"Instead of shipping a patient's cells to a distant factory, hospitals would make CAR-T on site under a shared licence, cutting cost and waiting time.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-reg-in-vivo-cart-off-the-shelf-vial","kind":"idea","name":"In vivo CAR-T as a vial on the shelf: a cost and access trial in lymphoma","route":"/ideas/idea-reg-in-vivo-cart-off-the-shelf-vial/","maturity":"early-clinical","tldr":"Some new medicines reprogramme immune cells inside the body with an injection, skipping the factory entirely. Test whether that makes CAR-T affordable and available in ordinary hospitals.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"},{"id":"in-vivo-car-t","kind":"technology","name":"In vivo CAR-T","route":"/technologies/in-vivo-car-t/"}]},{"id":"idea-reg-mutual-recognition-inspections-atmp","kind":"idea","name":"Mutual recognition of GMP inspections for cell, gene and radiopharmaceutical plants","route":"/ideas/idea-reg-mutual-recognition-inspections-atmp/","maturity":"early-clinical","tldr":"Factories making living or radioactive cancer medicines are inspected separately by each country. Accepting each other's inspections would free up inspectors and speed supply.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-neoadjuvant-io-glioblastoma","kind":"idea","name":"Neoadjuvant immunotherapy with surgical window for glioblastoma","route":"/ideas/idea-neoadjuvant-io-glioblastoma/","maturity":"early-clinical","tldr":"Give immunotherapy before surgery rather than after, so the tumour is still present to teach the immune system, then look inside it to learn what happened.","via":[{"id":"glioma-car-t","kind":"technology","name":"CAR-T for glioma (IL13Rα2, GD2, EGFRvIII, multi-target)","route":"/technologies/glioma-car-t/"}]},{"id":"idea-reg-open-source-lentiviral-vectors","kind":"idea","name":"Non-profit, open-licence lentiviral vectors and producer cell lines for CAR-T","route":"/ideas/idea-reg-open-source-lentiviral-vectors/","maturity":"early-clinical","tldr":"The engineered virus that delivers the CAR gene costs tens of thousands of dollars per patient and is controlled by a few suppliers. A non-profit supplier with open licences would cut that cost sharply.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-reg-non-viral-cart-manufacturing","kind":"idea","name":"Non-viral CAR-T (transposon or CRISPR knock-in) as the default manufacturing route","route":"/ideas/idea-reg-non-viral-cart-manufacturing/","maturity":"early-clinical","tldr":"Putting the CAR gene into T cells without a virus removes the most expensive and delay-prone ingredient. Test whether non-viral products match viral ones.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-fund-pay-for-cure-annuities","kind":"idea","name":"Outcome-based annuity payments for potentially curative one-time therapies","route":"/ideas/idea-fund-pay-for-cure-annuities/","maturity":"early-clinical","tldr":"Instead of paying hundreds of thousands up front for a CAR-T or gene therapy, the health system would pay in yearly instalments that stop if the cancer comes back, so companies are paid for cures, not attempts.","via":[{"id":"axicabtagene-ciloleucel","kind":"drug","name":"Axicabtagene ciloleucel","route":"/drugs/axicabtagene-ciloleucel/"},{"id":"ciltacabtagene-autoleucel","kind":"drug","name":"Ciltacabtagene autoleucel","route":"/drugs/ciltacabtagene-autoleucel/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-reg-annuity-payment-durable-therapies","kind":"idea","name":"Pay for one-time curative therapies as an annuity that stops at relapse","route":"/ideas/idea-reg-annuity-payment-durable-therapies/","maturity":"early-clinical","tldr":"A single cell therapy can cost more than a house. Paying in yearly instalments, only while the patient stays well, spreads the cost and shares the risk.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-moon-pay-for-cure-contracts","kind":"idea","name":"Pay-for-cure contracts: instalment payments for curative therapies contingent on durable remission","route":"/ideas/idea-moon-pay-for-cure-contracts/","maturity":"early-clinical","tldr":"For very expensive one-time treatments such as CAR-T, pay in instalments over years and stop paying if the cancer comes back, so price tracks the cure actually delivered.","via":[{"id":"axicabtagene-ciloleucel","kind":"drug","name":"Axicabtagene ciloleucel","route":"/drugs/axicabtagene-ciloleucel/"},{"id":"ciltacabtagene-autoleucel","kind":"drug","name":"Ciltacabtagene autoleucel","route":"/drugs/ciltacabtagene-autoleucel/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-peritoneal-directed-gastric","kind":"idea","name":"Peritoneal-directed therapy for gastric cancer","route":"/ideas/idea-peritoneal-directed-gastric/","maturity":"early-clinical","tldr":"Stomach cancer usually comes back on the abdominal lining, where drugs barely reach. Deliver treatment directly into the abdomen.","via":[{"id":"satricabtagene-autoleucel","kind":"drug","name":"Satricabtagene autoleucel","route":"/drugs/satricabtagene-autoleucel/"}]},{"id":"idea-bio1-adaptive-car-antigen-switch","kind":"idea","name":"Plan the second CAR-T target before the first one is lost","route":"/ideas/idea-bio1-adaptive-car-antigen-switch/","maturity":"early-clinical","tldr":"Cell therapies fail when the tumour stops showing the marker they were built to find. Preparing an alternative product in advance would let doctors switch quickly.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-reg-public-cell-therapy-foundries","kind":"idea","name":"Public cell-therapy foundries at cancer centres for academics and start-ups","route":"/ideas/idea-reg-public-cell-therapy-foundries/","maturity":"early-clinical","tldr":"Building a cell-therapy factory costs tens of millions, so most good academic ideas never reach patients. Shared public facilities would give them a route to the clinic.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-reg-academic-cart-at-cost-coverage","kind":"idea","name":"Public payers cover academic CAR-T at cost as a benchmark for commercial prices","route":"/ideas/idea-reg-academic-cart-at-cost-coverage/","maturity":"early-clinical","tldr":"Hospitals in Spain make their own CAR-T for a third of the commercial price. Paying for such products at cost gives health systems a lever in negotiating with companies.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-reg-cart-potency-reference-standards","kind":"idea","name":"Public reference standards and potency assays for CAR-T so every lab measures alike","route":"/ideas/idea-reg-cart-potency-reference-standards/","maturity":"early-clinical","tldr":"There is no agreed ruler for measuring how strong a CAR-T product is. Shared reference materials would let hospitals, companies and regulators compare products fairly.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-reg-lmic-public-cart-manufacturing","kind":"idea","name":"Public-sector CAR-T manufacturing in India, Brazil and South Africa under $50,000","route":"/ideas/idea-reg-lmic-public-cart-manufacturing/","maturity":"early-clinical","tldr":"India has shown CAR-T can be made for a tenth of the US price. Public production in large middle-income countries could make it available to millions who are currently excluded.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-reg-ipsc-master-bank-qualified-once","kind":"idea","name":"Qualify one iPSC master cell bank once for many off-the-shelf cell products","route":"/ideas/idea-reg-ipsc-master-bank-qualified-once/","maturity":"early-clinical","tldr":"Cell therapies made from a single stem cell line could be produced in bulk. Regulators should let companies certify the parent cell line once rather than repeating it for every product.","via":[{"id":"car-nk-macrophage","kind":"technology","name":"CAR-NK & CAR-macrophage","route":"/technologies/car-nk-macrophage/"}]},{"id":"idea-fund-translational-institutes-gmp","kind":"idea","name":"Regional translational institutes with academic GMP suites and IND teams","route":"/ideas/idea-fund-translational-institutes-gmp/","maturity":"early-clinical","tldr":"Build a handful of publicly-funded centres where academic discoveries can be manufactured to clinical grade and written up for regulators, so good ideas do not die for lack of a factory and a filing.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-mesothelin-car-t-regional","kind":"idea","name":"Regionally delivered mesothelin CAR-T with PD-1 blockade","route":"/ideas/idea-mesothelin-car-t-regional/","maturity":"early-clinical","tldr":"Deliver engineered T cells directly into the chest cavity where mesothelioma grows, and give immunotherapy to keep them working.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-fund-shared-personalised-therapy-gmp","kind":"idea","name":"Shared modular GMP facilities for academic personalised vaccines and cell products","route":"/ideas/idea-fund-shared-personalised-therapy-gmp/","maturity":"early-clinical","tldr":"Personalised cancer vaccines and cell therapies need a manufacturing run for each patient, and universities cannot afford their own plants. Regional closed, automated, modular GMP facilities offering slots to academic trials at cost, with common release testing and a shared quality system, modelled on the UK Cell and Gene Therapy Catapult centre, would let academic groups run these trials.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-bio2-intracavitary-immunotherapy","kind":"idea","name":"Treat the body cavity, not the bloodstream, for surface spread","route":"/ideas/idea-bio2-intracavitary-immunotherapy/","maturity":"early-clinical","tldr":"Intracavitary immunotherapy targets cancer that coats the lining of the abdomen or chest, which drugs given by drip barely reach. Delivering it straight into the cavity gives far higher local doses.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-reg-two-day-cart-rapid-release","kind":"idea","name":"Two-day CAR-T manufacture paired with rapid release tests that regulators accept","route":"/ideas/idea-reg-two-day-cart-rapid-release/","maturity":"early-clinical","tldr":"CAR-T can now be made in a day or two, but the safety tests to release it still take two weeks. Faster tests would let patients be treated within days.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-bio2-myeloid-engager-bispecific","kind":"idea","name":"Bispecific antibodies that engage macrophages instead of T cells","route":"/ideas/idea-bio2-myeloid-engager-bispecific/","maturity":"preclinical-evidence","tldr":"Drugs that grab T cells and drag them onto tumours work well in blood cancers. The same trick aimed at tumour-eating cells might work where T cells are absent.","via":[{"id":"car-nk-macrophage","kind":"technology","name":"CAR-NK & CAR-macrophage","route":"/technologies/car-nk-macrophage/"}]},{"id":"idea-bio2-intranasal-delivery","kind":"idea","name":"Deliver drugs and cells to the brain through the nose","route":"/ideas/idea-bio2-intranasal-delivery/","maturity":"preclinical-evidence","tldr":"The nerves at the top of the nose lead directly into the brain, bypassing the barrier. Nasal delivery of drugs, and even immune cells, has worked in animals.","via":[{"id":"car-nk-macrophage","kind":"technology","name":"CAR-NK & CAR-macrophage","route":"/technologies/car-nk-macrophage/"}]},{"id":"idea-reg-ai-process-control-cell-manufacturing","kind":"idea","name":"Digital batch records and AI process control to halve cell therapy batch failures","route":"/ideas/idea-reg-ai-process-control-cell-manufacturing/","maturity":"preclinical-evidence","tldr":"Autologous cell therapy batches fail more often than any other medicine because each patient's starting cells behave differently and the process runs without feedback. Inline sensors for metabolites, cell counts and cytokines, feeding models that adjust feeding and harvest timing in real time, could rescue batches that would otherwise be discarded.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-moon-in-vivo-cart-generic-price","kind":"idea","name":"In vivo CAR-T manufactured and priced like a generic biologic","route":"/ideas/idea-moon-in-vivo-cart-generic-price/","maturity":"preclinical-evidence","tldr":"Instead of making cell therapy from each patient's own cells in a factory, inject a particle that reprograms immune cells inside the body, made in bulk, so a dose costs thousands rather than hundreds of thousands.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"},{"id":"in-vivo-car-t","kind":"technology","name":"In vivo CAR-T","route":"/technologies/in-vivo-car-t/"}]},{"id":"idea-bio2-nk-cells-for-mrd","kind":"idea","name":"Off-the-shelf natural killer cells to sweep up residual disease","route":"/ideas/idea-bio2-nk-cells-for-mrd/","maturity":"preclinical-evidence","tldr":"Donor immune cells that need no matching could be given as short courses to clear the few cancer cells left after surgery, when the target is smallest.","via":[{"id":"car-nk-macrophage","kind":"technology","name":"CAR-NK & CAR-macrophage","route":"/technologies/car-nk-macrophage/"}]},{"id":"idea-bio2-fus-for-cell-entry","kind":"idea","name":"Open the barrier so engineered immune cells can enter the brain","route":"/ideas/idea-bio2-fus-for-cell-entry/","maturity":"preclinical-evidence","tldr":"Engineered immune cells given by drip rarely reach brain tumours. Briefly opening the barrier with focused ultrasound at the right moment may let them in.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"},{"id":"glioma-car-t","kind":"technology","name":"CAR-T for glioma (IL13Rα2, GD2, EGFRvIII, multi-target)","route":"/technologies/glioma-car-t/"},{"id":"car-nk-macrophage","kind":"technology","name":"CAR-NK & CAR-macrophage","route":"/technologies/car-nk-macrophage/"}]},{"id":"idea-reg-manufacturing-slot-exchange","kind":"idea","name":"A neutral slot exchange so unused CAR-T manufacturing slots go to the next patient","route":"/ideas/idea-reg-manufacturing-slot-exchange/","maturity":"speculative","tldr":"Patients wait weeks for a manufacturing slot while other slots go unused when a patient drops out. A shared booking system would match spare slots to waiting patients.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-reg-closed-manufacturing-interop-standard","kind":"idea","name":"An open interoperability standard for closed automated cell-processing machines","route":"/ideas/idea-reg-closed-manufacturing-interop-standard/","maturity":"speculative","tldr":"Each cell-therapy machine uses its own proprietary process and cartridges. A common standard would let a process run on any machine, like a document opening in any word processor.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-reg-comparability-by-design-digital-twin","kind":"idea","name":"Comparability by design: a digital twin and sentinel panel for cell process changes","route":"/ideas/idea-reg-comparability-by-design-digital-twin/","maturity":"speculative","tldr":"Improving how a cell therapy is made currently risks having to repeat clinical trials. A validated computer model plus a fixed set of product measurements would let changes be approved on data alone.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-moon-engineered-immune-surveillance","kind":"idea","name":"Engineered immune surveillance: long-lived programmed immune cells that patrol for early cancer","route":"/ideas/idea-moon-engineered-immune-surveillance/","maturity":"speculative","tldr":"For people at very high cancer risk, install a small population of engineered immune cells that live for years and destroy cells showing early cancer signals before a tumour forms.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"},{"id":"car-nk-macrophage","kind":"technology","name":"CAR-NK & CAR-macrophage","route":"/technologies/car-nk-macrophage/"}]},{"id":"idea-bispecific-vs-car-t-second-line","kind":"idea","name":"Head-to-head bispecific vs CAR-T in second-line LBCL","route":"/ideas/idea-bispecific-vs-car-t-second-line/","maturity":"speculative","tldr":"Nobody has directly compared an off-the-shelf bispecific with CAR-T in the same patients; a trial would settle where each belongs.","via":[{"id":"axicabtagene-ciloleucel","kind":"drug","name":"Axicabtagene ciloleucel","route":"/drugs/axicabtagene-ciloleucel/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-in-vivo-car-solid","kind":"idea","name":"In vivo CAR-T against solid-tumour antigens","route":"/ideas/idea-in-vivo-car-solid/","maturity":"speculative","tldr":"If a lipid nanoparticle can make CAR-T cells inside the body for lymphoma, it could be redosed weekly against solid-tumour targets that autologous CAR-T cannot sustain.","via":[{"id":"satricabtagene-autoleucel","kind":"drug","name":"Satricabtagene autoleucel","route":"/drugs/satricabtagene-autoleucel/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"},{"id":"in-vivo-car-t","kind":"technology","name":"In vivo CAR-T","route":"/technologies/in-vivo-car-t/"}]},{"id":"idea-reg-vein-to-vein-public-benchmark","kind":"idea","name":"Mandatory public reporting of vein-to-vein time and failure rate per CAR-T product","route":"/ideas/idea-reg-vein-to-vein-public-benchmark/","maturity":"speculative","tldr":"Patients and doctors cannot see how long each CAR-T maker takes or how often manufacturing fails. Publishing this would create pressure to get faster and more reliable.","via":[{"id":"axicabtagene-ciloleucel","kind":"drug","name":"Axicabtagene ciloleucel","route":"/drugs/axicabtagene-ciloleucel/"},{"id":"ciltacabtagene-autoleucel","kind":"drug","name":"Ciltacabtagene autoleucel","route":"/drugs/ciltacabtagene-autoleucel/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]},{"id":"idea-bio1-organoid-cell-therapy-potency","kind":"idea","name":"Use patient organoids to check a cell therapy will work before infusing it","route":"/ideas/idea-bio1-organoid-cell-therapy-potency/","maturity":"speculative","tldr":"Cell therapies are tested for purity and count, but not for whether they can actually kill that patient's tumour. Testing them against the patient's own mini-tumour would show this.","via":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}]}],"manufacturing":{"sites":[{"id":"bms-devens","name":"Bristol Myers Squibb Devens","operator":"Bristol Myers Squibb","operatorRoute":"/companies/bms/","ownership":"in-house","city":"Devens, Massachusetts","country":"US","capabilities":["cell-therapy","antibody-drug-substance"],"capabilityLabels":["Cell therapy","Antibody drug substance"],"drugs":[{"id":"idecabtagene-vicleucel","kind":"drug","name":"Idecabtagene vicleucel","route":"/drugs/idecabtagene-vicleucel/"},{"id":"lisocabtagene-maraleucel","kind":"drug","name":"Lisocabtagene maraleucel","route":"/drugs/lisocabtagene-maraleucel/"}],"source":{"label":"BMS manufacturing","url":"https://www.bms.com/"}},{"id":"cellares-south-sf","name":"Cellares Smart Factory","operator":"Cellares","operatorRoute":"/companies/cellares/","ownership":"cdmo","city":"South San 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ciloleucel","route":"/drugs/axicabtagene-ciloleucel/"}],"source":{"label":"Kite manufacturing","url":"https://www.kitepharma.com/"}},{"id":"kite-hoofddorp","name":"Kite Hoofddorp","operator":"Kite (Gilead)","operatorRoute":"/companies/gilead/","ownership":"in-house","city":"Hoofddorp","country":"NL","capabilities":["cell-therapy"],"capabilityLabels":["Cell therapy"],"drugs":[{"id":"axicabtagene-ciloleucel","kind":"drug","name":"Axicabtagene ciloleucel","route":"/drugs/axicabtagene-ciloleucel/"}],"source":{"label":"Kite manufacturing","url":"https://www.kitepharma.com/"}},{"id":"legend-raritan","name":"Legend Biotech and Janssen Raritan","operator":"Legend Biotech with Johnson & Johnson","operatorRoute":"/companies/legend-biotech/","ownership":"in-house","city":"Raritan, New Jersey","country":"US","capabilities":["cell-therapy"],"capabilityLabels":["Cell therapy"],"drugs":[{"id":"ciltacabtagene-autoleucel","kind":"drug","name":"Ciltacabtagene autoleucel","route":"/drugs/ciltacabtagene-autoleucel/"}],"source":{"label":"Legend Biotech","url":"https://www.legendbiotech.com/"}},{"id":"legend-ghent","name":"Legend Biotech Ghent (Tech Lane)","operator":"Legend Biotech with Johnson & Johnson","operatorRoute":"/companies/legend-biotech/","ownership":"in-house","city":"Ghent","country":"BE","capabilities":["cell-therapy"],"capabilityLabels":["Cell therapy"],"drugs":[{"id":"ciltacabtagene-autoleucel","kind":"drug","name":"Ciltacabtagene autoleucel","route":"/drugs/ciltacabtagene-autoleucel/"}],"source":{"label":"Legend Biotech","url":"https://www.legendbiotech.com/"}},{"id":"miltenyi-bergisch-gladbach","name":"Miltenyi Biotec","operator":"Miltenyi Biotec","operatorRoute":"/companies/miltenyi-biotec/","ownership":"cdmo","city":"Bergisch Gladbach","country":"DE","capabilities":["cell-therapy","viral-vector"],"capabilityLabels":["Cell therapy","Viral vector"],"drugs":[],"source":{"label":"Miltenyi Biotec","url":"https://www.miltenyibiotec.com/"}},{"id":"novartis-morris-plains","name":"Novartis Morris Plains","operator":"Novartis","operatorRoute":"/companies/novartis/","ownership":"in-house","city":"Morris Plains, New Jersey","country":"US","capabilities":["cell-therapy"],"capabilityLabels":["Cell therapy"],"drugs":[{"id":"tisagenlecleucel","kind":"drug","name":"Tisagenlecleucel","route":"/drugs/tisagenlecleucel/"}],"source":{"label":"Novartis cell therapy","url":"https://www.novartis.com/"}},{"id":"oxford-biomedica-oxford","name":"Oxford Biomedica Oxbox","operator":"Oxford Biomedica","operatorRoute":"/companies/oxford-biomedica/","ownership":"cdmo","city":"Oxford","country":"GB","capabilities":["viral-vector"],"capabilityLabels":["Viral vector"],"drugs":[],"source":{"label":"Oxford Biomedica","url":"https://www.oxb.com/"}}],"capabilities":["Cell therapy","Viral vector"],"chain":{"id":"cell-therapy","name":"Cell therapy","summary":"Apheresis, vector, closed manufacturing, cryopreservation and chain of identity, release testing, point of care and allogeneic banks.","route":"/manufacturing/#chain-cell-therapy","technologies":[{"id":"apheresis-starting-material","kind":"technology","name":"Apheresis and starting-material collection","route":"/technologies/apheresis-starting-material/"},{"id":"viral-vector-manufacturing","kind":"technology","name":"Viral vector manufacturing (lentiviral, retroviral, AAV)","route":"/technologies/viral-vector-manufacturing/"},{"id":"car-t-manufacturing-process","kind":"technology","name":"Autologous CAR-T manufacturing, batch by batch","route":"/technologies/car-t-manufacturing-process/"},{"id":"closed-automated-cell-manufacturing","kind":"technology","name":"Closed automated cell-therapy manufacturing","route":"/technologies/closed-automated-cell-manufacturing/"},{"id":"cell-therapy-cold-chain","kind":"technology","name":"Cryopreservation and cell-therapy cold chain","route":"/technologies/cell-therapy-cold-chain/"},{"id":"cell-therapy-orchestration-software","kind":"technology","name":"Cell-therapy orchestration and chain-of-identity software","route":"/technologies/cell-therapy-orchestration-software/"},{"id":"cell-therapy-release-testing","kind":"technology","name":"Cell-therapy release and potency testing","route":"/technologies/cell-therapy-release-testing/"},{"id":"point-of-care-cell-manufacturing","kind":"technology","name":"Point-of-care and decentralised cell manufacturing","route":"/technologies/point-of-care-cell-manufacturing/"},{"id":"allogeneic-cell-banks","kind":"technology","name":"Allogeneic cell banks: one donor, hundreds of doses","route":"/technologies/allogeneic-cell-banks/"}],"companies":[{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"},{"id":"gilead","kind":"company","name":"Gilead Sciences (incl. Kite)","route":"/companies/gilead/"},{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"},{"id":"legend-biotech","kind":"company","name":"Legend Biotech","route":"/companies/legend-biotech/"},{"id":"autolus","kind":"company","name":"Autolus Therapeutics","route":"/companies/autolus/"},{"id":"oxford-biomedica","kind":"company","name":"OXB (Oxford Biomedica)","route":"/companies/oxford-biomedica/"},{"id":"miltenyi-biotec","kind":"company","name":"Miltenyi Biotec","route":"/companies/miltenyi-biotec/"},{"id":"cytiva","kind":"company","name":"Cytiva (Danaher)","route":"/companies/cytiva/"},{"id":"lonza","kind":"company","name":"Lonza","route":"/companies/lonza/"},{"id":"cellares","kind":"company","name":"Cellares","route":"/companies/cellares/"},{"id":"cryoport","kind":"company","name":"Cryoport","route":"/companies/cryoport/"},{"id":"terumo-bct","kind":"company","name":"Terumo Blood and Cell Technologies","route":"/companies/terumo-bct/"},{"id":"cellectis","kind":"company","name":"Cellectis","route":"/companies/cellectis/"},{"id":"allogene","kind":"company","name":"Allogene Therapeutics","route":"/companies/allogene/"},{"id":"immunoact","kind":"company","name":"ImmunoACT","route":"/companies/immunoact/"}],"products":[{"id":"tisagenlecleucel","kind":"drug","name":"Tisagenlecleucel","route":"/drugs/tisagenlecleucel/"},{"id":"axicabtagene-ciloleucel","kind":"drug","name":"Axicabtagene ciloleucel","route":"/drugs/axicabtagene-ciloleucel/"},{"id":"lisocabtagene-maraleucel","kind":"drug","name":"Lisocabtagene maraleucel","route":"/drugs/lisocabtagene-maraleucel/"},{"id":"idecabtagene-vicleucel","kind":"drug","name":"Idecabtagene vicleucel","route":"/drugs/idecabtagene-vicleucel/"},{"id":"ciltacabtagene-autoleucel","kind":"drug","name":"Ciltacabtagene autoleucel","route":"/drugs/ciltacabtagene-autoleucel/"},{"id":"obecabtagene-autoleucel","kind":"drug","name":"Obecabtagene autoleucel","route":"/drugs/obecabtagene-autoleucel/"},{"id":"lifileucel","kind":"drug","name":"Lifileucel","route":"/drugs/lifileucel/"}]},"technologies":[{"id":"car-t-manufacturing-process","kind":"technology","name":"Autologous CAR-T manufacturing, batch by batch","route":"/technologies/car-t-manufacturing-process/","tldr":"Each CAR-T dose is a separate factory run for one patient: collect their T cells, activate them, add the CAR gene with a virus, grow them for a week or two, freeze, test and ship them back. The steps, the failure points and the waiting list are all here."},{"id":"apheresis-starting-material","kind":"technology","name":"Apheresis and starting-material collection","route":"/technologies/apheresis-starting-material/","tldr":"Apheresis is collecting a patient's white blood cells through a machine over several hours. Every autologous CAR-T begins here, and the quality of these cells shapes the final product."},{"id":"cell-therapy-cold-chain","kind":"technology","name":"Cryopreservation and cell-therapy cold chain","route":"/technologies/cell-therapy-cold-chain/","tldr":"Freezing cells at minus 150 degrees and shipping them in liquid-nitrogen 'dry shippers' with tracking, so a living drug arrives alive and matched to the right patient."},{"id":"point-of-care-cell-manufacturing","kind":"technology","name":"Point-of-care and decentralised cell manufacturing","route":"/technologies/point-of-care-cell-manufacturing/","tldr":"Making CAR-T cells at or near the hospital instead of shipping cells to a central factory and back."}]},"drugs":[{"id":"adi-270","kind":"drug","name":"ADI-270","route":"/drugs/adi-270/"},{"id":"anitocabtagene-autoleucel","kind":"drug","name":"Anitocabtagene autoleucel","route":"/drugs/anitocabtagene-autoleucel/"},{"id":"ard103","kind":"drug","name":"ARD103","route":"/drugs/ard103/"},{"id":"arlocabtagene-autoleucel","kind":"drug","name":"Arlocabtagene Autoleucel","route":"/drugs/arlocabtagene-autoleucel/"},{"id":"at101","kind":"drug","name":"AT101","route":"/drugs/at101/"},{"id":"axicabtagene-ciloleucel","kind":"drug","name":"Axicabtagene ciloleucel","route":"/drugs/axicabtagene-ciloleucel/"},{"id":"azd0120","kind":"drug","name":"AZD0120","route":"/drugs/azd0120/"},{"id":"azd4045","kind":"drug","name":"AZD4045","route":"/drugs/azd4045/"},{"id":"bcb-276","kind":"drug","name":"BCB-276","route":"/drugs/bcb-276/"},{"id":"brexucabtagene-autoleucel","kind":"drug","name":"Brexucabtagene autoleucel","route":"/drugs/brexucabtagene-autoleucel/"},{"id":"cart84","kind":"drug","name":"CART84","route":"/drugs/cart84/"},{"id":"ciltacabtagene-autoleucel","kind":"drug","name":"Ciltacabtagene autoleucel","route":"/drugs/ciltacabtagene-autoleucel/"},{"id":"crc01","kind":"drug","name":"CRC01","route":"/drugs/crc01/"},{"id":"ctx112","kind":"drug","name":"CTX112","route":"/drugs/ctx112/"},{"id":"dji136","kind":"drug","name":"DJI136","route":"/drugs/dji136/"},{"id":"eb-car30-nk","kind":"drug","name":"EB-CAR30-NK","route":"/drugs/eb-car30-nk/"},{"id":"eb-nk-301","kind":"drug","name":"EB-NK-301","route":"/drugs/eb-nk-301/"},{"id":"equecabtagene-autoleucel","kind":"drug","name":"Equecabtagene autoleucel","route":"/drugs/equecabtagene-autoleucel/"},{"id":"gc012f","kind":"drug","name":"GC012F","route":"/drugs/gc012f/"},{"id":"idecabtagene-vicleucel","kind":"drug","name":"Idecabtagene vicleucel","route":"/drugs/idecabtagene-vicleucel/"},{"id":"inaticabtagene-autoleucel","kind":"drug","name":"Inaticabtagene autoleucel","route":"/drugs/inaticabtagene-autoleucel/"},{"id":"jnj-90014496","kind":"drug","name":"JNJ-90014496","route":"/drugs/jnj-90014496/"},{"id":"lisocabtagene-maraleucel","kind":"drug","name":"Lisocabtagene maraleucel","route":"/drugs/lisocabtagene-maraleucel/"},{"id":"nxc-201-car-t","kind":"drug","name":"NXC-201 CAR-T","route":"/drugs/nxc-201-car-t/"},{"id":"obecabtagene-autoleucel","kind":"drug","name":"Obecabtagene autoleucel","route":"/drugs/obecabtagene-autoleucel/"},{"id":"relmacabtagene-autoleucel","kind":"drug","name":"Relmacabtagene autoleucel","route":"/drugs/relmacabtagene-autoleucel/"},{"id":"rondecabtagene-autoleucel","kind":"drug","name":"Rondecabtagene autoleucel","route":"/drugs/rondecabtagene-autoleucel/"},{"id":"satricabtagene-autoleucel","kind":"drug","name":"Satricabtagene autoleucel","route":"/drugs/satricabtagene-autoleucel/"},{"id":"talicabtagene-autoleucel","kind":"drug","name":"Talicabtagene autoleucel","route":"/drugs/talicabtagene-autoleucel/"},{"id":"tbi-1501","kind":"drug","name":"TBI-1501","route":"/drugs/tbi-1501/"},{"id":"tc011","kind":"drug","name":"TC011","route":"/drugs/tc011/"},{"id":"tisagenlecleucel","kind":"drug","name":"Tisagenlecleucel","route":"/drugs/tisagenlecleucel/"},{"id":"ucart22","kind":"drug","name":"UCART22","route":"/drugs/ucart22/"},{"id":"varnimcabtagene-autoleucel","kind":"drug","name":"Varnimcabtagene autoleucel","route":"/drugs/varnimcabtagene-autoleucel/"},{"id":"zamtocabtagene-autoleucel","kind":"drug","name":"Zamtocabtagene autoleucel","route":"/drugs/zamtocabtagene-autoleucel/"},{"id":"zevorcabtagene-autoleucel","kind":"drug","name":"Zevorcabtagene autoleucel","route":"/drugs/zevorcabtagene-autoleucel/"}],"note":"Every section is read from existing corpus records and names them (from, via, exemplars, refs); a section with nothing behind it is empty. Medicines of a format are the open drug engine's (/pipeline/engine/); technologies are listed in src/lib/modular-formats.ts. CC BY-NC 4.0, attribute Data from OnCo (onco.cc). Not medical advice."}