{"entity":{"id":"transcend-nhl-001","kind":"trial","name":"TRANSCEND NHL 001","aka":["JCAR017","liso-cel pivotal study","TRANSCEND NHL 001"],"tldr":"The study that registered the third CAR-T cell product for lymphoma, built from a fixed one-to-one mix of two kinds of T cell, with fewer severe immune side effects than its predecessors.","summary":"Lisocabtagene maraleucel differs from the other two approved CD19 products in that the CD8 and CD4 chimeric antigen receptor T cells are manufactured separately and infused at equal target doses rather than as whatever ratio the patient's apheresis happened to contain. TRANSCEND NHL 001 was a seamless design study at 14 United States centres that tested three dose levels in sequence.\n\nOf 344 patients who had leukapheresis, 269 received at least one dose. They had a median of three previous lines, 42 per cent were 65 or older, 67 per cent had chemotherapy-refractory disease and seven had secondary central nervous system involvement, a group usually excluded. In the 256 patients of 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. Safety and activity did not differ by dose level, and the recommended target dose was 100 million chimeric antigen receptor positive T cells.\n\nThe toxicity figures are why the product is used in older and frailer patients: cytokine release syndrome in 42 per cent but grade 3 or worse in only 2 per cent, neurological events in 30 per cent with 10 per cent grade 3 or worse. One patient died of diffuse alveolar damage after a dose-limiting toxicity.","status":"positive","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT02631044","url":"https://clinicaltrials.gov/study/NCT02631044"},{"label":"Lancet 2020","url":"https://doi.org/10.1016/S0140-6736(20)31366-0"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["dlbcl","non-hodgkin-lymphoma","follicular-lymphoma","primary-mediastinal-b-cell-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","lymphoma-tx-car-t-pathway"],"trials":["transform","zuma-1","juliet"],"people":[],"bottlenecks":["b-manufacturing-cell-therapy","b-aging-comorbidity"],"keyPapers":["paper-transcend-nhl-001-liso-cel-lancet-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02631044","phase":"1","setting":"Relapsed or refractory large B-cell lymphoma after at least one prior line, including double-hit and transformed disease: lisocabtagene maraleucel at three dose levels","sponsor":"Juno Therapeutics, a Subsidiary of Celgene","result":"Objective response in 73 per cent and complete response in 53 per cent of 256 evaluable patients, with grade 3 or worse cytokine release syndrome in 2 per cent.","started":"2016-01-06","startedType":"actual","yearReported":2020,"enrolled":269,"enrolledBasis":"treated","enrolledNote":"The registry records 387 enrolled; 344 underwent leukapheresis and 269 received at least one dose of lisocabtagene maraleucel, of whom 256 were in the efficacy-evaluable set.","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Lisocabtagene maraleucel","n":256,"value":73}],"ci":[66.8,78],"source":"https://doi.org/10.1016/S0140-6736(20)31366-0"},{"endpoint":"Complete response rate","unit":"%","arms":[{"name":"Lisocabtagene maraleucel","n":256,"value":53}],"ci":[46.8,59.4]},{"endpoint":"Grade 3 or worse cytokine release syndrome","unit":"%","arms":[{"name":"Lisocabtagene maraleucel","n":269,"value":2}]}],"replication":"Confirmed in the randomised second-line setting by TRANSFORM."},"route":"/trials/transcend-nhl-001/","neighbours":{"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/"},{"id":"lymphoma-tx-car-t-pathway","kind":"term","name":"The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting","route":"/terms/lymphoma-tx-car-t-pathway/"}],"trial":[{"id":"belinda","kind":"trial","name":"BELINDA","route":"/trials/belinda/"},{"id":"juliet","kind":"trial","name":"JULIET","route":"/trials/juliet/"},{"id":"transform","kind":"trial","name":"TRANSFORM","route":"/trials/transform/"},{"id":"zuma-1","kind":"trial","name":"ZUMA-1","route":"/trials/zuma-1/"},{"id":"zuma-7","kind":"trial","name":"ZUMA-7","route":"/trials/zuma-7/"}],"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/"}],"paper":[{"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","route":"/key-papers/paper-transcend-nhl-001-liso-cel-lancet-2020/"}],"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/"}],"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/"}]}}