{"entity":{"id":"talicabtagene-autoleucel","kind":"drug","name":"Talicabtagene autoleucel","aka":["tali-cel","actalycabtagene autoleucel (earlier name)","HCAR19"],"tldr":"India's first home-grown CAR-T cell therapy, approved in 2023 for relapsed leukaemia and lymphoma, made in Mumbai for roughly a tenth of what the same kind of treatment costs in the US.","summary":"Talicabtagene autoleucel (NexCAR19) is an autologous CD19-directed CAR-T therapy with a humanised binder developed at IIT Bombay (Rahul Purwar) with Tata Memorial Centre and manufactured by ImmunoACT in Mumbai. The open-label phase 1/2 study enrolled 64 patients (14 in phase 1, 50 in phase 2) with relapsed or refractory B-cell lymphoma or B-cell acute lymphoblastic leukaemia at six Indian centres; among 51 evaluable patients the overall response rate was 73% (37 of 51; 95% CI 59-83), grade 3 or worse neutropenia occurred in 96%, and there were two treatment-related deaths. The DCGI granted market authorisation in 2023, the first CAR-T approval in India and one of the first in any lower-middle-income country.\n\nThe product's significance is economic as much as clinical: ImmunoACT reports more than 600 patients treated at over 130 centres, a 98% manufacturing success rate and about 20 days from apheresis to infusion, at a price reported to be around a tenth of that of US products. The company's real-world series and a 2026 distribution deal with Cipla for Africa make it the test case for whether autologous cell therapy can reach middle-income countries at scale.","status":"approved","asOf":"2026-09-10","links":[{"label":"ImmunoACT: NexCAR19","url":"https://immunoact.com"},{"label":"Phase 1/2 study (Lancet Haematol 2025)","url":"https://doi.org/10.1016/S2352-3026(24)00377-6"},{"label":"Commentary: CAR T-cell therapy in LMICs (Lancet Haematol 2025)","url":"https://doi.org/10.1016/S2352-3026(25)00040-7"}],"tags":[],"related":["tisagenlecleucel","idea-reg-lmic-public-cart-manufacturing"],"cancers":["dlbcl","all-leukemia"],"sections":[],"technologies":["car-t","point-of-care-cell-manufacturing"],"targets":["cd19"],"drugs":[],"companies":["immunoact","cipla"],"institutions":["tata-memorial","actrec","iit-bombay"],"pathways":[],"terms":["crs","icans"],"trials":["talicel-phase-1-2"],"people":["purwar-rahul","jain-hasmukh","narula-gaurav"],"bottlenecks":["b-manufacturing-cell-therapy","b-global-access","b-drug-pricing"],"keyPapers":["paper-jain-talicabtagene-lancet-haem-2025"],"journals":[],"dependsOn":[],"notes":[],"brand":"NexCAR19","code":"NexCAR19","modality":"CAR-T (CD19, humanised)","mechanism":"Autologous T cells transduced with a lentiviral humanised anti-CD19 scFv CAR with 4-1BB costimulation and CD3-zeta signalling; expand in vivo and kill CD19-positive B cells after lymphodepletion.","approvals":[{"region":"IN","year":2023,"indication":"Relapsed or refractory B-cell lymphoma and B-cell acute lymphoblastic leukaemia","note":"DCGI market authorisation; first CAR-T approved in India"}],"mechanismSteps":["Leukapheresis collects the patient's T cells at an authorised centre","Cells are shipped to Mumbai, transduced with the humanised CD19 CAR and expanded (about 20 days end to end)","Lymphodepleting chemotherapy makes room for the infused cells","CAR-T cells find CD19 on lymphoma or leukaemia cells and kill them; cytokine release and neurotoxicity are watched for","B-cell aplasia persists while the cells remain active"],"dosing":{"route":"Single IV infusion after lymphodepletion","schedule":"Phase 2 dose at least 5 x 10^6 CAR-T cells per kg (up to 2 x 10^9 cells)","monitoring":"Cytokine release syndrome, neurotoxicity, prolonged cytopenias, infection, haemophagocytic lymphohistiocytosis-like syndrome","source":"https://doi.org/10.1016/S2352-3026(24)00377-6"},"toxicity":[{"event":"Neutropenia (grade 3 or worse)","grade3PlusPct":96,"source":"https://doi.org/10.1016/S2352-3026(24)00377-6","note":"Phase 1/2, 64 patients"},{"event":"Thrombocytopenia (grade 3 or worse)","grade3PlusPct":65,"source":"https://doi.org/10.1016/S2352-3026(24)00377-6"},{"event":"Anaemia (grade 3 or worse)","grade3PlusPct":61,"source":"https://doi.org/10.1016/S2352-3026(24)00377-6"}],"access":[{"country":"IN","listPrice":"Priced by the developer at a small fraction of US CAR-T prices; no figure is published on the linked page","reimbursement":"Public insurance cover not established; ask the treating centre about state and charitable funding","generic":false,"source":"https://immunoact.com","asOf":"2026-09-10"}],"regulatoryEvents":[{"date":"2023","type":"approval","region":"IN","note":"CDSCO/DCGI market authorisation; the developer's page gives the year only","source":"https://immunoact.com"}]},"route":"/drugs/talicabtagene-autoleucel/","neighbours":{"drug":[{"id":"tisagenlecleucel","kind":"drug","name":"Tisagenlecleucel","route":"/drugs/tisagenlecleucel/"},{"id":"varnimcabtagene-autoleucel","kind":"drug","name":"Varnimcabtagene autoleucel","route":"/drugs/varnimcabtagene-autoleucel/"}],"idea":[{"id":"idea-reg-lmic-public-cart-manufacturing","kind":"idea","name":"Public-sector CAR-T manufacturing in India, Brazil and South Africa under $50,000","route":"/ideas/idea-reg-lmic-public-cart-manufacturing/"}],"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/"}],"company":[{"id":"cipla","kind":"company","name":"Cipla","route":"/companies/cipla/"},{"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":"icans","kind":"term","name":"ICANS (neurotoxicity)","route":"/terms/icans/"}],"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/"},{"id":"b-drug-pricing","kind":"bottleneck","name":"Prices and value","route":"/bottlenecks/b-drug-pricing/"}],"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/"}],"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/"}]}}