# Talicabtagene autoleucel (NexCAR19) phase 1/2

Source: https://onco.cc/trials/talicel-phase-1-2/  
OnCo record `talicel-phase-1-2` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-10
- 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
- Enrolled: 64
- Result: ORR 73% (37 of 51) in relapsed or refractory B-cell malignancies; two treatment-related deaths.
- Outcomes: Overall response rate: Talicabtagene autoleucel 73%

## Sources

- Jain et al., Lancet Haematology 2025: https://doi.org/10.1016/S2352-3026(24)00377-6

## Connected records

- 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/)
- drugs: [Talicabtagene autoleucel](https://onco.cc/drugs/talicabtagene-autoleucel/)
- companies: [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/), [Objective response rate (ORR)](https://onco.cc/terms/orr/)
- 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/)
- 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/)
- ideas: [In vivo CAR-T as a vial on the shelf: a cost and access trial in lymphoma](https://onco.cc/ideas/idea-reg-in-vivo-cart-off-the-shelf-vial/), [Non-viral CAR-T (transposon or CRISPR knock-in) as the default manufacturing route](https://onco.cc/ideas/idea-reg-non-viral-cart-manufacturing/)
- 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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