{"entity":{"id":"talicel-phase-1-2","kind":"trial","name":"Talicabtagene autoleucel (NexCAR19) phase 1/2","aka":[],"tldr":"The trial behind India's first CAR-T approval: about three in four heavily pretreated patients with lymphoma or leukaemia responded to a therapy made in Mumbai.","summary":"64 patients were enrolled (14 in the phase 1 dose escalation, 50 in phase 2) at six tertiary cancer centres; the phase 2 dose was at least 5 x 10^6 CAR-T cells per kg (up to 2 x 10^9). Among 51 efficacy-evaluable patients (36 B-cell lymphoma, 15 B-ALL) the overall response rate was 73% (37 of 51; 95% CI 59-83). Grade 3 or worse haematological toxicity was near universal (neutropenia 96%, thrombocytopenia 65%, anaemia 61%) and two deaths were treatment related (one febrile neutropenia with haemophagocytic lymphohistiocytosis and septic shock, one pulmonary bleed with multi-organ dysfunction and cytokine release syndrome). Published in Lancet Haematology in 2025 with a commentary on CAR-T in lower-income countries.","status":"positive","asOf":"2026-09-10","links":[{"label":"Jain et al., Lancet Haematology 2025","url":"https://doi.org/10.1016/S2352-3026(24)00377-6"}],"tags":[],"related":[],"cancers":["dlbcl","all-leukemia"],"sections":[],"technologies":["car-t","point-of-care-cell-manufacturing"],"targets":["cd19"],"drugs":["talicabtagene-autoleucel"],"companies":["immunoact"],"institutions":["tata-memorial","actrec","iit-bombay"],"pathways":[],"terms":["orr","crs"],"trials":[],"people":["jain-hasmukh","narula-gaurav","purwar-rahul"],"bottlenecks":["b-manufacturing-cell-therapy","b-global-access"],"keyPapers":["paper-jain-talicabtagene-lancet-haem-2025"],"journals":[],"dependsOn":[],"notes":[],"phase":"1/2","setting":"Relapsed or refractory B-cell lymphoma and B-cell acute lymphoblastic leukaemia, adults and adolescents, six Indian tertiary centres","sponsor":"ImmunoACT with Tata Memorial Centre","result":"ORR 73% (37 of 51) in relapsed or refractory B-cell malignancies; two treatment-related deaths.","yearReported":2025,"enrolled":64,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall response rate","primary":true,"unit":"%","arms":[{"name":"Talicabtagene autoleucel","n":51,"value":73,"note":"95% CI 59-83"}],"source":"https://doi.org/10.1016/S2352-3026(24)00377-6"}]},"route":"/trials/talicel-phase-1-2/","neighbours":{"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"},{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"}],"technology":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/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/"}],"target":[{"id":"cd19","kind":"target","name":"CD19","route":"/targets/cd19/"}],"drug":[{"id":"talicabtagene-autoleucel","kind":"drug","name":"Talicabtagene autoleucel","route":"/drugs/talicabtagene-autoleucel/"}],"company":[{"id":"immunoact","kind":"company","name":"ImmunoACT","route":"/companies/immunoact/"}],"institution":[{"id":"actrec","kind":"institution","name":"Advanced Centre for Treatment, Research and Education in Cancer","route":"/institutions/actrec/"},{"id":"iit-bombay","kind":"institution","name":"Indian Institute of Technology Bombay","route":"/institutions/iit-bombay/"},{"id":"tata-memorial","kind":"institution","name":"Tata Memorial Centre","route":"/institutions/tata-memorial/"}],"term":[{"id":"crs","kind":"term","name":"Cytokine release syndrome (CRS)","route":"/terms/crs/"},{"id":"orr","kind":"term","name":"Objective response rate (ORR)","route":"/terms/orr/"}],"person":[{"id":"narula-gaurav","kind":"person","name":"Gaurav Narula","route":"/people/narula-gaurav/"},{"id":"jain-hasmukh","kind":"person","name":"Hasmukh Jain","route":"/people/jain-hasmukh/"},{"id":"purwar-rahul","kind":"person","name":"Rahul Purwar","route":"/people/purwar-rahul/"}],"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-global-access","kind":"bottleneck","name":"Most of the world has almost no cancer care","route":"/bottlenecks/b-global-access/"}],"paper":[{"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/"}],"idea":[{"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/"},{"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/"}],"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/"}]}}