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.
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.
The 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.
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. Connects to CD19.
1.Leukapheresis collects the patient's T cells at an authorised centre
Source: doi.org/10.1016/S2352-3026(24)00377-6. Doses are for orientation; the current label governs.
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CDSCO/DCGI market authorisation; the developer's page gives the year only source
| Region | Year | Indication |
|---|---|---|
| IN | 2023 | Relapsed or refractory B-cell lymphoma and B-cell acute lymphoblastic leukaemia · DCGI market authorisation; first CAR-T approved in India |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Neutropenia (grade 3 or worse) | - | 96% |
| Thrombocytopenia (grade 3 or worse) | - | 65% |
| Anaemia (grade 3 or worse) | - | 61% |
Phase 1/2, 64 patients. Rates read from the source. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| IN | Public insurance cover not established; ask the treating centre about state and charitable funding | Priced by the developer at a small fraction of US CAR-T prices; no figure is published on the linked page | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Query for this drug: (TITLE:"Talicabtagene autoleucel" OR ABSTRACT:"Talicabtagene autoleucel" OR TITLE:"NexCAR19" OR ABSTRACT:"NexCAR19" OR TITLE:"tali-cel" OR ABSTRACT:"tali-cel" OR TITLE:"actalycabtagene autoleucel earlier name" OR ABSTRACT:"actalycabtagene autoleucel earlier name" OR TITLE:"HCAR19" OR ABSTRACT:"HCAR19") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Talicabtagene autoleucel, not a curated reading list.
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Shares Indian Institute of Technology Bombay, Point-of-care and decentralised cell manufacturing, ImmunoACT, Manufacturing cost and time for living and radioactive medicines.
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