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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.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
Shares Point-of-care and decentralised cell manufacturing, Cytokine release syndrome (CRS), Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Manufacturing cost and time for living and radioactive medicines.
Shares Talicabtagene autoleucel, Tata Memorial Centre, Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Manufacturing cost and time for living and radioactive medicines.
Shares Point-of-care and decentralised cell manufacturing, Talicabtagene autoleucel, Cytokine release syndrome (CRS), Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation.
Shares Point-of-care and decentralised cell manufacturing, Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Manufacturing cost and time for living and radioactive medicines, CD19.
Shares Non-viral CAR-T (transposon or CRISPR knock-in) as the default manufacturing route, In vivo CAR-T as a vial on the shelf: a cost and access trial in lymphoma, Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, CD19.
Shares ImmunoACT, Talicabtagene autoleucel, Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Most of the world has almost no cancer care.
Shares Non-viral CAR-T (transposon or CRISPR knock-in) as the default manufacturing route, In vivo CAR-T as a vial on the shelf: a cost and access trial in lymphoma, CAR-T cell therapy, Diffuse large B-cell lymphoma.
Shares Indian Institute of Technology Bombay, Point-of-care and decentralised cell manufacturing, ImmunoACT, Manufacturing cost and time for living and radioactive medicines.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/