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death","drugs":1,"examples":[{"id":"lifileucel","kind":"drug","name":"Lifileucel","route":"/drugs/lifileucel/"}]}],"drugsWithToxicity":1},"resistance":[],"papers":[{"id":"paper-quantum-first-quizartinib-lancet-2023","kind":"paper","name":"QuANTUM-First: quizartinib added to intensive chemotherapy and continued as maintenance in newly diagnosed FLT3-ITD AML","route":"/key-papers/paper-quantum-first-quizartinib-lancet-2023/","year":2023,"journal":"The Lancet","paperType":"rct","tldr":"Adding the FLT3 inhibitor quizartinib to standard chemotherapy, and continuing it for up to three years, roughly doubled median survival in FLT3-ITD acute myeloid leukaemia.","via":[{"id":"allogeneic-hsct","kind":"technology","name":"Allogeneic stem cell transplantation","route":"/technologies/allogeneic-hsct/"}]},{"id":"paper-rohaas-til-vs-ipilimumab-nejm-2022","kind":"paper","name":"Rohaas 2022: the first randomised trial of TIL therapy, against ipilimumab, in advanced melanoma","route":"/key-papers/paper-rohaas-til-vs-ipilimumab-nejm-2022/","year":2022,"journal":"New England Journal of Medicine","paperType":"rct","tldr":"In a head-to-head trial, tumour-infiltrating lymphocyte therapy halved the risk of progression compared with ipilimumab in melanoma that had mostly already failed PD-1 blockade.","via":[{"id":"aldesleukin","kind":"drug","name":"Aldesleukin (high-dose IL-2)","route":"/drugs/aldesleukin/"},{"id":"lifileucel","kind":"drug","name":"Lifileucel","route":"/drugs/lifileucel/"},{"id":"tacquell","kind":"drug","name":"Tacquell (autologous melanoma-derived tumour-infiltrating lymphocytes)","route":"/drugs/tacquell/"},{"id":"til-therapy","kind":"technology","name":"TIL therapy","route":"/technologies/til-therapy/"}]},{"id":"paper-c-144-01-lifileucel-melanoma-jco-2021","kind":"paper","name":"C-144-01: lifileucel, tumour-infiltrating lymphocytes grown from a patient's own tumour, in melanoma after checkpoint inhibitors have failed","route":"/key-papers/paper-c-144-01-lifileucel-melanoma-jco-2021/","year":2021,"journal":"Journal of Clinical Oncology","paperType":"translational","tldr":"Immune cells harvested from a patient's tumour, expanded in the lab and reinfused shrank melanoma in 36% of patients whose disease had progressed on PD-1 blockade, with responses that mostly lasted.","via":[{"id":"aldesleukin","kind":"drug","name":"Aldesleukin (high-dose IL-2)","route":"/drugs/aldesleukin/"},{"id":"lifileucel","kind":"drug","name":"Lifileucel","route":"/drugs/lifileucel/"},{"id":"til-therapy","kind":"technology","name":"TIL therapy","route":"/technologies/til-therapy/"}]},{"id":"paper-depil-nat-rev-drug-discov","kind":"paper","name":"'Off-the-shelf' allogeneic CAR T cells: development and challenges","route":"/key-papers/paper-depil-nat-rev-drug-discov/","year":2020,"journal":"Nature Reviews Drug Discovery","paperType":"review","tldr":"Paper cited by one technology page, indexed on Europe PMC as PubMed record 31900462 and published in Nature Reviews Drug Discovery; the citing page links this DOI, which is how the record was matched.","via":[{"id":"allogeneic-cell-therapy","kind":"technology","name":"Allogeneic (off-the-shelf) cell therapy","route":"/technologies/allogeneic-cell-therapy/"}]},{"id":"paper-msb-gvhd001-bbmt-2020","kind":"paper","name":"A phase 3, single-arm, prospective study of remestemcel-L, ex vivo culture-expanded adult human mesenchymal stromal cells for the treatment of pediatric patients who failed to respond to steroid treatment for acute graft-versus-host disease","route":"/key-papers/paper-msb-gvhd001-bbmt-2020/","year":2020,"journal":"Biology of Blood and Marrow Transplantation","paperType":"observational","tldr":"The primary report of MSB-GVHD001: seven in ten children with steroid-refractory acute graft-versus-host disease responded to remestemcel-L by day 28, well above the 45 percent historical rate, and responders were far more likely to be alive at six months.","via":[{"id":"remestemcel-l","kind":"drug","name":"Remestemcel-L","route":"/drugs/remestemcel-l/"}]},{"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":"allogeneic-cell-therapy","kind":"technology","name":"Allogeneic (off-the-shelf) cell therapy","route":"/technologies/allogeneic-cell-therapy/"},{"id":"allogeneic-cell-banking","kind":"technology","name":"Allogeneic donor and iPSC master cell banks","route":"/technologies/allogeneic-cell-banking/"}]},{"id":"paper-admiral-gilteritinib-flt3-nejm-2019","kind":"paper","name":"ADMIRAL: gilteritinib pills versus chemotherapy for relapsed FLT3-mutated acute myeloid leukaemia","route":"/key-papers/paper-admiral-gilteritinib-flt3-nejm-2019/","year":2019,"journal":"New England Journal of Medicine","paperType":"rct","tldr":"An oral FLT3 inhibitor extended survival compared with salvage chemotherapy in relapsed AML with a FLT3 mutation, doubling the remission rate.","via":[{"id":"allogeneic-hsct","kind":"technology","name":"Allogeneic stem cell transplantation","route":"/technologies/allogeneic-hsct/"}]},{"id":"paper-ino-vate-inotuzumab-all-nejm-2016","kind":"paper","name":"INO-VATE: inotuzumab ozogamicin, a CD22 antibody-drug conjugate, versus chemotherapy for relapsed adult B-cell ALL","route":"/key-papers/paper-ino-vate-inotuzumab-all-nejm-2016/","year":2016,"journal":"New England Journal of Medicine","paperType":"rct","tldr":"A CD22 antibody-drug conjugate produced complete remission in 81% of adults with relapsed ALL compared with 29% on chemotherapy, at the cost of liver toxicity in about one in ten.","via":[{"id":"allogeneic-hsct","kind":"technology","name":"Allogeneic stem cell transplantation","route":"/technologies/allogeneic-hsct/"}]},{"id":"paper-study-0201-blood-2006","kind":"paper","name":"Improved leukemia-free survival after postconsolidation immunotherapy with histamine dihydrochloride and interleukin-2 in acute myeloid leukemia: results of a randomized phase 3 trial","route":"/key-papers/paper-study-0201-blood-2006/","year":2006,"journal":"Blood","paperType":"rct","tldr":"The primary report of Study 0201: adding histamine dihydrochloride to low-dose interleukin-2 after consolidation improved leukaemia-free survival in acute myeloid leukaemia, with 40 percent against 26 percent leukaemia-free at three years in first remission.","via":[{"id":"aldesleukin","kind":"drug","name":"Aldesleukin (high-dose IL-2)","route":"/drugs/aldesleukin/"}]}],"eras":[{"roadmap":{"id":"cell-therapy-roadmap","kind":"roadmap","name":"Cell therapy roadmap: 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A public network would scale that so more patients can be treated for less.","via":[{"id":"allogeneic-cell-therapy","kind":"technology","name":"Allogeneic (off-the-shelf) cell therapy","route":"/technologies/allogeneic-cell-therapy/"}]},{"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":"til-therapy","kind":"technology","name":"TIL therapy","route":"/technologies/til-therapy/"}]},{"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":"allogeneic-cell-therapy","kind":"technology","name":"Allogeneic (off-the-shelf) cell therapy","route":"/technologies/allogeneic-cell-therapy/"}]},{"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":"allogeneic-cell-therapy","kind":"technology","name":"Allogeneic (off-the-shelf) cell therapy","route":"/technologies/allogeneic-cell-therapy/"}]},{"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":"til-therapy","kind":"technology","name":"TIL therapy","route":"/technologies/til-therapy/"}]},{"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":"allogeneic-cell-therapy","kind":"technology","name":"Allogeneic (off-the-shelf) cell therapy","route":"/technologies/allogeneic-cell-therapy/"}]},{"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":"til-therapy","kind":"technology","name":"TIL therapy","route":"/technologies/til-therapy/"}]},{"id":"idea-bio1-clonal-neoantigen-vaccines","kind":"idea","name":"Vaccines aimed only at mutations shared by every tumour cell","route":"/ideas/idea-bio1-clonal-neoantigen-vaccines/","maturity":"early-clinical","tldr":"Personal cancer vaccines target a list of mutations, some present in only part of the tumour, so the tumour can escape by losing them. Restricting vaccines and T-cell products to clonal mutations shared by every tumour cell, identified by multi-region sequencing, should close that escape route.","via":[{"id":"til-therapy","kind":"technology","name":"TIL therapy","route":"/technologies/til-therapy/"}]},{"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":"til-therapy","kind":"technology","name":"TIL therapy","route":"/technologies/til-therapy/"}]},{"id":"idea-bio1-organoid-immune-coculture","kind":"idea","name":"Grow tumour organoids together with the patient's own immune cells","route":"/ideas/idea-bio1-organoid-immune-coculture/","maturity":"preclinical-evidence","tldr":"Lab-grown mini-tumours usually contain only cancer cells. Adding the patient's own immune cells lets researchers test immunotherapy outside the body.","via":[{"id":"til-therapy","kind":"technology","name":"TIL therapy","route":"/technologies/til-therapy/"}]},{"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":"allogeneic-cell-therapy","kind":"technology","name":"Allogeneic (off-the-shelf) cell therapy","route":"/technologies/allogeneic-cell-therapy/"}]},{"id":"idea-bio2-til-reactivity-selection","kind":"idea","name":"Select patients for cell therapy by whether their tumour holds reactive T cells","route":"/ideas/idea-bio2-til-reactivity-selection/","maturity":"preclinical-evidence","tldr":"Growing a patient's own tumour-fighting cells only works if those cells are there to start with. A test for them would spare futile treatment.","via":[{"id":"lifileucel","kind":"drug","name":"Lifileucel","route":"/drugs/lifileucel/"},{"id":"til-therapy","kind":"technology","name":"TIL therapy","route":"/technologies/til-therapy/"}]},{"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":"til-therapy","kind":"technology","name":"TIL therapy","route":"/technologies/til-therapy/"}]},{"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":"lifileucel","kind":"drug","name":"Lifileucel","route":"/drugs/lifileucel/"},{"id":"til-therapy","kind":"technology","name":"TIL therapy","route":"/technologies/til-therapy/"}]}],"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 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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":"allogeneic-cell-banks","kind":"technology","name":"Allogeneic cell banks: one donor, hundreds of doses","route":"/technologies/allogeneic-cell-banks/","tldr":"Instead of making CAR-T cells from each patient, take T cells from a healthy donor or from a stem cell line, edit them so the patient's body will not fight them, grow a huge batch and freeze it into hundreds of doses that sit on a shelf."},{"id":"allogeneic-cell-banking","kind":"technology","name":"Allogeneic donor and iPSC master cell banks","route":"/technologies/allogeneic-cell-banking/","tldr":"Making cell therapies from a healthy donor or stem-cell line in advance, so patients get an off-the-shelf product instead of waiting weeks."}]},"drugs":[{"id":"aldesleukin","kind":"drug","name":"Aldesleukin (high-dose IL-2)","route":"/drugs/aldesleukin/"},{"id":"cd19-t-hank","kind":"drug","name":"CD19 t-haNK","route":"/drugs/cd19-t-hank/"},{"id":"dorocubicel","kind":"drug","name":"Dorocubicel (UM171-expanded cord blood)","route":"/drugs/dorocubicel/"},{"id":"gc101-til","kind":"drug","name":"GC101 TIL","route":"/drugs/gc101-til/"},{"id":"lifileucel","kind":"drug","name":"Lifileucel","route":"/drugs/lifileucel/"},{"id":"omidubicel","kind":"drug","name":"Omidubicel","route":"/drugs/omidubicel/"},{"id":"remestemcel-l","kind":"drug","name":"Remestemcel-L","route":"/drugs/remestemcel-l/"},{"id":"tabelecleucel","kind":"drug","name":"Tabelecleucel","route":"/drugs/tabelecleucel/"},{"id":"tacquell","kind":"drug","name":"Tacquell (autologous melanoma-derived tumour-infiltrating lymphocytes)","route":"/drugs/tacquell/"},{"id":"tara-002","kind":"drug","name":"TARA-002","route":"/drugs/tara-002/"}],"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."}