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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.