{"entity":{"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","aka":[],"tldr":"The trial report behind India's first CAR-T therapy: about three in four heavily pretreated patients with lymphoma or leukaemia responded to cells engineered and made in Mumbai.","summary":"Open-label phase 1/2 study at six Indian tertiary centres enrolling 64 patients (14 phase 1, 50 phase 2) with relapsed or refractory B-cell lymphoma or B-ALL; phase 2 dose at least 5 x 10^6 CAR-T cells per kg (up to 2 x 10^9). Among 51 efficacy-evaluable patients (36 lymphoma, 15 B-ALL) the overall response rate was 73% (37 of 51; 95% CI 59-83). Grade 3 or worse neutropenia (96%), thrombocytopenia (65%) and anaemia (61%) were common; two deaths were treatment related. An accompanying commentary framed the approval as a model for CAR-T in lower-income countries.","asOf":"2026-09-10","links":[{"label":"Lancet Haematology 2025","url":"https://doi.org/10.1016/S2352-3026(24)00377-6"},{"label":"Commentary: CAR T-cell therapy in LMICs","url":"https://doi.org/10.1016/S2352-3026(25)00040-7"}],"tags":[],"related":[],"cancers":["dlbcl","all-leukemia"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["talicabtagene-autoleucel"],"companies":["immunoact"],"institutions":["tata-memorial","iit-bombay"],"pathways":[],"terms":[],"trials":["talicel-phase-1-2"],"people":["jain-hasmukh","narula-gaurav","purwar-rahul"],"bottlenecks":["b-manufacturing-cell-therapy","b-global-access"],"keyPapers":[],"journals":["lancet-haematology"],"dependsOn":[],"notes":[],"journal":"Lancet Haematology","year":2025,"doi":"10.1016/S2352-3026(24)00377-6","pmid":"40090352","authors":"Jain H, Karulkar A, Kalra D, et al.","paperType":"rct","findings":["Overall response rate 73% (37 of 51 evaluable patients).","Grade 3 or worse neutropenia in 96%, thrombocytopenia 65%, anaemia 61%.","Two treatment-related deaths (one with haemophagocytic lymphohistiocytosis and septic shock, one pulmonary bleed with cytokine release syndrome).","Product manufactured domestically with a humanised CD19 binder; approved by the DCGI in 2023."],"whatItMeans":"A lower-middle-income country can design, manufacture, trial and approve an autologous CAR-T therapy. Response rates are in the range of first-generation Western products in similar mixed populations, at a price an order of magnitude lower, which reopens the question of what CAR-T should cost everywhere.","caveats":["Single-arm, small, mixed histologies; durability data are short.","Response assessment and comparability to pivotal Western trials (which used disease-specific cohorts and complete response endpoints) are limited.","Haematological toxicity was very high and two deaths were treatment related; safety systems at 130-plus centres matter."],"changedPractice":true,"participants":64},"route":"/key-papers/paper-jain-talicabtagene-lancet-haem-2025/","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/"}],"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":"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/"}],"trial":[{"id":"talicel-phase-1-2","kind":"trial","name":"Talicabtagene autoleucel (NexCAR19) phase 1/2","route":"/trials/talicel-phase-1-2/"}],"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/"}],"journal":[{"id":"lancet-haematology","kind":"journal","name":"The Lancet Haematology","route":"/journals/lancet-haematology/"}]}}