Talicabtagene autoleucel (NexCAR19) phase 1/2
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.
Overview
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.
- 73 out of 100 people had their tumour shrink with Talicabtagene autoleucel.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- These results apply to the people the trial enrolled: Relapsed or refractory B-cell lymphoma and B-cell acute lymphoblastic leukaemia, adults and adolescents, six Indian tertiary centres. People in a different situation may not see the same effect.
- Only 64 people took part, so the numbers are less certain than in a large trial.
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.
Pages like this
not linked directly; found by shared links- IdeaPublic-sector CAR-T manufacturing in India, Brazil and South Africa under $50,000
Shares Talicabtagene autoleucel, Tata Memorial Centre, Manufacturing cost and time for living and radioactive medicines, Most of the world has almost no cancer care.
- ProductVarnimcabtagene autoleucel
Shares Talicabtagene autoleucel, Cytokine release syndrome (CRS), CD19, Manufacturing cost and time for living and radioactive medicines.
- TrialIMAGINE (varnimcabtagene autoleucel, Immuneel)
Shares Cytokine release syndrome (CRS), CD19, Manufacturing cost and time for living and radioactive medicines, Most of the world has almost no cancer care.
- TechnologyPoint-of-care and decentralised cell manufacturing
Shares Rahul Purwar, Indian Institute of Technology Bombay, ImmunoACT, Advanced Centre for Treatment, Research and Education in Cancer.
- CompanyCipla
Shares ImmunoACT, Talicabtagene autoleucel, Most of the world has almost no cancer care, CAR-T cell therapy.
- CompanyCellogen Therapeutics
Shares CD19, Manufacturing cost and time for living and radioactive medicines, Acute lymphoblastic leukaemia, Diffuse large B-cell lymphoma.
- Key paperJULIET: tisagenlecleucel for adults with relapsed or refractory diffuse large B-cell lymphoma
Shares Objective response rate (ORR), Cytokine release syndrome (CRS), CD19, Manufacturing cost and time for living and radioactive medicines.
- TrialELIANA
Shares Cytokine release syndrome (CRS), CD19, Manufacturing cost and time for living and radioactive medicines, Acute lymphoblastic leukaemia.