# Talicabtagene autoleucel for relapsed or refractory B-cell malignancies: an open-label, multicentre, phase 1/2 study

Source: https://onco.cc/key-papers/paper-jain-talicabtagene-lancet-haem-2025/  
OnCo record `paper-jain-talicabtagene-lancet-haem-2025` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Key paper
- Last checked: 2026-09-10
- Journal: Lancet Haematology
- Year: 2025
- DOI: 10.1016/S2352-3026(24)00377-6
- Authors: Jain H, Karulkar A, Kalra D, et al.
- 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.
- What it means: 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.

## Sources

- Lancet Haematology 2025: https://doi.org/10.1016/S2352-3026(24)00377-6
- Commentary: CAR T-cell therapy in LMICs: https://doi.org/10.1016/S2352-3026(25)00040-7

## 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/)
- drugs: [Talicabtagene autoleucel](https://onco.cc/drugs/talicabtagene-autoleucel/)
- companies: [ImmunoACT](https://onco.cc/companies/immunoact/)
- institutions: [Indian Institute of Technology Bombay](https://onco.cc/institutions/iit-bombay/), [Tata Memorial Centre](https://onco.cc/institutions/tata-memorial/)
- 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/)
- journals: [The Lancet Haematology](https://onco.cc/journals/lancet-haematology/)

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