# Talicabtagene autoleucel

Source: https://onco.cc/drugs/talicabtagene-autoleucel/  
OnCo record `talicabtagene-autoleucel` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Also known as: tali-cel; actalycabtagene autoleucel (earlier name); HCAR19
- 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: IN 2023: Relapsed or refractory B-cell lymphoma and B-cell acute lymphoblastic leukaemia
- Dosing: Single IV infusion after lymphodepletion; Phase 2 dose at least 5 x 10^6 CAR-T cells per kg (up to 2 x 10^9 cells)
- Toxicity (grade 3+): Neutropenia (grade 3 or worse) 96%; Thrombocytopenia (grade 3 or worse) 65%; Anaemia (grade 3 or worse) 61%

## Sources

- ImmunoACT: NexCAR19: https://immunoact.com
- Phase 1/2 study (Lancet Haematol 2025): https://doi.org/10.1016/S2352-3026(24)00377-6
- Commentary: CAR T-cell therapy in LMICs (Lancet Haematol 2025): https://doi.org/10.1016/S2352-3026(25)00040-7

## Connected records

- drugs: [Tisagenlecleucel](https://onco.cc/drugs/tisagenlecleucel/), [Varnimcabtagene autoleucel](https://onco.cc/drugs/varnimcabtagene-autoleucel/)
- ideas: [Public-sector CAR-T manufacturing in India, Brazil and South Africa under $50,000](https://onco.cc/ideas/idea-reg-lmic-public-cart-manufacturing/)
- cancers: [Acute lymphoblastic leukaemia](https://onco.cc/cancers/all-leukemia/), [Diffuse large B-cell lymphoma](https://onco.cc/cancers/dlbcl/)
- technologies: [CAR-T cell therapy](https://onco.cc/technologies/car-t/), [Point-of-care and decentralised cell manufacturing](https://onco.cc/technologies/point-of-care-cell-manufacturing/)
- targets: [CD19](https://onco.cc/targets/cd19/)
- companies: [Cipla](https://onco.cc/companies/cipla/), [ImmunoACT](https://onco.cc/companies/immunoact/)
- institutions: [Advanced Centre for Treatment, Research and Education in Cancer](https://onco.cc/institutions/actrec/), [Indian Institute of Technology Bombay](https://onco.cc/institutions/iit-bombay/), [Tata Memorial Centre](https://onco.cc/institutions/tata-memorial/)
- terms: [Cytokine release syndrome (CRS)](https://onco.cc/terms/crs/), [ICANS (neurotoxicity)](https://onco.cc/terms/icans/)
- trials: [Talicabtagene autoleucel (NexCAR19) phase 1/2](https://onco.cc/trials/talicel-phase-1-2/)
- people: [Gaurav Narula](https://onco.cc/people/narula-gaurav/), [Hasmukh Jain](https://onco.cc/people/jain-hasmukh/), [Rahul Purwar](https://onco.cc/people/purwar-rahul/)
- bottlenecks: [Manufacturing cost and time for living and radioactive medicines](https://onco.cc/bottlenecks/b-manufacturing-cell-therapy/), [Most of the world has almost no cancer care](https://onco.cc/bottlenecks/b-global-access/), [Prices and value](https://onco.cc/bottlenecks/b-drug-pricing/)
- key papers: [Talicabtagene autoleucel for relapsed or refractory B-cell malignancies: an open-label, multicentre, phase 1/2 study](https://onco.cc/key-papers/paper-jain-talicabtagene-lancet-haem-2025/)
- roadmaps: [Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation](https://onco.cc/roadmaps/global-access-roadmap/)

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