{"entity":{"id":"paper-transcend-nhl-001-liso-cel-lancet-2020","kind":"paper","name":"Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study","aka":["TRANSCEND NHL 001","Abramson 2020","JCAR017 pivotal study"],"tldr":"The pivotal study of the third CAR-T product for lymphoma, built from a fixed one-to-one mix of two kinds of T cell, with severe immune side effects in only a small minority.","summary":"A seamless design study at 14 United States cancer centres in adults with relapsed or refractory large B-cell lymphomas, including diffuse large B-cell lymphoma, high-grade B-cell lymphoma with MYC and BCL2, BCL6 or both rearranged, transformed disease, primary mediastinal B-cell lymphoma and grade 3B follicular lymphoma. Three target dose levels were tested in sequence, each given as a sequential infusion of separately manufactured CD8 and CD4 chimeric antigen receptor positive T cells at equal target doses.\n\nBetween 11 January 2016 and 5 July 2019, 344 patients underwent leukapheresis and 269 received at least one dose. Patients had a median of three previous lines, 112 (42 per cent) were 65 or older, 181 (67 per cent) had chemotherapy-refractory disease and seven (3 per cent) had secondary central nervous system involvement. Safety and activity did not differ by dose level, and the recommended target dose was 100 million chimeric antigen receptor positive T cells. Of 256 patients in the efficacy-evaluable set, 186 (73 per cent, 95 per cent confidence interval 66.8 to 78.0) had an objective response and 136 (53 per cent, 46.8 to 59.4) a complete response.","asOf":"2026-10-01","links":[{"label":"Lancet 2020","url":"https://doi.org/10.1016/S0140-6736(20)31366-0"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/32888407/"},{"label":"Europe PMC","url":"https://europepmc.org/article/MED/32888407"}],"tags":["lymphoma-evidence"],"related":["lymphoma-roadmap"],"cancers":["dlbcl","non-hodgkin-lymphoma","primary-mediastinal-b-cell-lymphoma","follicular-lymphoma"],"sections":["cell-therapy"],"technologies":["car-t"],"targets":["cd19"],"drugs":["lisocabtagene-maraleucel"],"companies":["bms"],"institutions":[],"pathways":[],"terms":["crs","icans","orr","complete-response","double-hit-lymphoma"],"trials":["transcend-nhl-001","transform"],"people":[],"bottlenecks":["b-manufacturing-cell-therapy","b-aging-comorbidity"],"keyPapers":[],"journals":["lancet"],"dependsOn":[],"notes":[],"journal":"Lancet","year":2020,"doi":"10.1016/S0140-6736(20)31366-0","pmid":"32888407","authors":"Abramson JS, Palomba ML, Gordon LI, et al.","paperType":"rct","findings":["Of 256 efficacy-evaluable patients, 186 (73 per cent, 95 per cent confidence interval 66.8 to 78.0) achieved an objective response and 136 (53 per cent, 46.8 to 59.4) a complete response.","Cytokine release syndrome occurred in 113 patients (42 per cent) but was grade 3 or worse in only six (2 per cent).","Neurological events occurred in 80 patients (30 per cent), grade 3 or worse in 27 (10 per cent).","The most common grade 3 or worse adverse events were neutropenia (60 per cent), anaemia (37 per cent) and thrombocytopenia (27 per cent).","Overall safety and activity did not differ by dose level; the recommended target dose was 100 million chimeric antigen receptor positive T cells."],"whatItMeans":"The evidence that made lisocabtagene maraleucel the CD19 CAR-T product most often chosen for older or frailer patients, because its severe cytokine release syndrome rate is a fraction of the other two products'.","caveats":["Single-arm and not randomised; the comparison with the other CD19 products rests on cross-trial inference with different eligibility and bridging rules.","Of 344 patients who had leukapheresis, 75 never received the product, which is the real-world attrition that single-arm response rates hide.","14 United States centres with CAR-T experience, so the toxicity figures reflect expert management."],"changedPractice":true,"participants":269},"route":"/key-papers/paper-transcend-nhl-001-liso-cel-lancet-2020/","neighbours":{"roadmap":[{"id":"lymphoma-roadmap","kind":"roadmap","name":"Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting","route":"/roadmaps/lymphoma-roadmap/"}],"cancer":[{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"},{"id":"follicular-lymphoma","kind":"cancer","name":"Follicular lymphoma","route":"/cancers/follicular-lymphoma/"},{"id":"non-hodgkin-lymphoma","kind":"cancer","name":"Non-Hodgkin lymphoma (all types)","route":"/cancers/non-hodgkin-lymphoma/"},{"id":"primary-mediastinal-b-cell-lymphoma","kind":"cancer","name":"Primary mediastinal (thymic) large B-cell lymphoma","route":"/cancers/primary-mediastinal-b-cell-lymphoma/"}],"section":[{"id":"cell-therapy","kind":"section","name":"Cell Therapy","route":"/fronts/cell-therapy/"}],"technology":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}],"target":[{"id":"cd19","kind":"target","name":"CD19","route":"/targets/cd19/"}],"drug":[{"id":"lisocabtagene-maraleucel","kind":"drug","name":"Lisocabtagene maraleucel","route":"/drugs/lisocabtagene-maraleucel/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"}],"term":[{"id":"complete-response","kind":"term","name":"Complete response","route":"/terms/complete-response/"},{"id":"crs","kind":"term","name":"Cytokine release syndrome (CRS)","route":"/terms/crs/"},{"id":"double-hit-lymphoma","kind":"term","name":"Double-hit / high-grade B-cell lymphoma","route":"/terms/double-hit-lymphoma/"},{"id":"icans","kind":"term","name":"ICANS (neurotoxicity)","route":"/terms/icans/"},{"id":"orr","kind":"term","name":"Objective response rate (ORR)","route":"/terms/orr/"}],"trial":[{"id":"transcend-nhl-001","kind":"trial","name":"TRANSCEND NHL 001","route":"/trials/transcend-nhl-001/"},{"id":"transform","kind":"trial","name":"TRANSFORM","route":"/trials/transform/"}],"bottleneck":[{"id":"b-manufacturing-cell-therapy","kind":"bottleneck","name":"Manufacturing cost and time for living and radioactive medicines","route":"/bottlenecks/b-manufacturing-cell-therapy/"},{"id":"b-aging-comorbidity","kind":"bottleneck","name":"Older and multimorbid patients are excluded and undertreated","route":"/bottlenecks/b-aging-comorbidity/"}],"journal":[{"id":"lancet","kind":"journal","name":"The Lancet","route":"/journals/lancet/"}],"idea":[{"id":"lymphoma-ev-manufacturing-time-as-a-trial-endpoint","kind":"idea","name":"Report the time from apheresis to infusion as a trial endpoint, not a logistics footnote","route":"/ideas/lymphoma-ev-manufacturing-time-as-a-trial-endpoint/"}],"paper":[{"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/"},{"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/"}]}}