{"entity":{"id":"transcend-cll-004","kind":"trial","name":"TRANSCEND CLL 004","aka":[],"tldr":"The study that brought CAR-T to CLL: one in five heavily pretreated patients achieved complete remission, most of them lasting.","summary":"TRANSCEND CLL 004, trial NCT03331198 sponsored by Bristol Myers Squibb through Juno and published in the Lancet in 2023, is the study that brought CAR-T to chronic lymphocytic leukaemia: about one in five heavily pretreated patients achieved complete remission with lisocabtagene maraleucel, most of them lasting. In the primary analysis set of patients who had failed a BTK inhibitor and venetoclax, complete remission occurred in about a fifth, nearly half responded and most had undetectable MRD in blood, with complete responders in remission beyond two years, leading to accelerated approval on 14 March 2024. OnCo links it to chronic lymphocytic leukaemia, CAR-T, CD19 as a target and lisocabtagene maraleucel. Efficacy is lower than in lymphoma, reflecting T-cell dysfunction in CLL, and whether that can be overcome is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03331198","url":"https://clinicaltrials.gov/study/NCT03331198"}],"tags":[],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":["car-t"],"targets":["cd19"],"drugs":["lisocabtagene-maraleucel"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03331198","phase":"1/2","setting":"Relapsed/refractory CLL/SLL after BTK inhibitor (and venetoclax in the primary analysis set): lisocabtagene maraleucel","sponsor":"BMS / Juno","result":"CR/CRi 18-20%; ORR 47%; uMRD blood 64%.","started":"2017-11-27","startedType":"actual","yearReported":2023,"enrolled":137,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete response / CRi (primary analysis set)","primary":true,"unit":"%","arms":[{"name":"Liso-cel","n":49,"value":18}],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01052-8/fulltext"},{"endpoint":"Overall response rate","unit":"%","arms":[{"name":"Liso-cel","value":47}],"source":"https://doi.org/10.1016/S0140-6736(23)01052-8"},{"endpoint":"Undetectable MRD in blood","unit":"%","arms":[{"name":"Liso-cel","value":64}],"source":"https://doi.org/10.1016/S0140-6736(23)01052-8"}],"replication":"Academic CD19 CAR-T series in CLL (Penn, Seattle) report similar CR rates and show ibrutinib co-administration improves T-cell fitness."},"route":"/trials/transcend-cll-004/","neighbours":{"cancer":[{"id":"cll","kind":"cancer","name":"Chronic lymphocytic leukaemia","route":"/cancers/cll/"},{"id":"cll-relapsed","kind":"cancer","name":"Relapsed or refractory chronic lymphocytic leukaemia","route":"/cancers/cll-relapsed/"}],"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/"}]}}