India's homegrown CAR T-cell therapy reports outcomes in 250 patients across 56 centres

A multicentre real-world study of talicabtagene autoleucel, India's first domestically developed CD19-directed CAR T-cell therapy, has reported delivery, efficacy and safety outcomes in 250 patients treated at 56 centres across the country. It was published in Blood Cancer Journal on 16 July 2026 under the digital object identifier 10.1038/s41408-026-01569-w. It is the largest CAR-T dataset published from a low- or middle-income country.

Talicabtagene autoleucel is known as tali-cel and marketed as NexCAR19. It is the first humanised CD19-directed CAR T-cell therapy approved in India, cleared by CDSCO in October 2023 for relapsed or refractory B-cell acute lymphoblastic leukaemia and B-cell non-Hodgkin lymphoma. It was developed jointly by the Indian Institute of Technology Bombay, Tata Memorial Centre and ImmunoACT (Immunoadoptive Cell Therapy Private Limited) of Mumbai.

The cohort was 105 patients with relapsed or refractory B-cell acute lymphoblastic leukaemia and 145 with relapsed or refractory B-cell non-Hodgkin lymphoma, 250 in total, all of whom underwent leukapheresis between 15 November 2023 and 31 January 2025.

The study's central operational finding concerns a centralised coordination unit model. Manufacturing slots were allocated within one week of request, and the median vein-to-vein time, from apheresis to infusion, was 29 days, with a range of 16 to 102 days. That interval was independent of the patient's geographic location within India.

Among the leukaemia patients, median follow-up was 14 months. Median overall survival was not reached and median progression-free survival was 18 months, with a range of 9 months to not reached. Twelve-month overall survival was 64 per cent (95% CI 53 to 72) and twelve-month progression-free survival was 55 per cent (95% CI 45 to 65).

Among the lymphoma patients, median follow-up was 13 months. Median progression-free survival was 11 months, with a range of 7 to 16 months, and median overall survival was not reached. Twelve-month overall survival was 63 per cent (95% CI 54 to 71) and twelve-month progression-free survival was 47 per cent (95% CI 38 to 56). No patient in the cohort underwent consolidative stem cell transplantation, which is notable because in many Western series transplant is used to consolidate CAR-T responses.

Grade 3 or 4 cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome and immune effector cell-associated haemophagocytic lymphohistiocytosis-like syndrome occurred in 6 per cent, 4 per cent and 23 per cent of the leukaemia patients respectively. The corresponding figures among the lymphoma patients were 6 per cent, 3 per cent and 18 per cent.

The first author is Atharva Karulkar of ImmunoACT, Mumbai. The corresponding author is Hasmukh Jain of the Department of Medical Oncology at Tata Memorial Hospital, Homi Bhabha National University, Mumbai. The work is credited to the Real World Consortium. Participating centres span the country and include Tata Memorial Hospital in Mumbai, Amrita Hospital in Kochi and Faridabad, the Rajiv Gandhi Cancer Institute and Research Centre in New Delhi, Deenanath Mangeshkar Hospital in Pune, Basavatarakam Indo American Cancer Hospital in Hyderabad, the Cancer Institute WIA at Adyar in Chennai, Malabar Cancer Centre in Thalassery, Fortis Hospital in Gurugram, St John's Medical College Hospital in Bengaluru, Apollo Cancer Centre in Visakhapatnam and Kovai Medical Centre in Coimbatore.

The author list also includes collaborators in the United States: Nirali N. Shah of the Pediatric Oncology Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda; Terry Fry of the University of Colorado and Children's Hospital Colorado; and Nitin Jain and Sattva Neelapu of the University of Texas MD Anderson Cancer Center. The real-world cohort is registered as CTRI/2025/08/093795. The earlier phase 1/2 trial of tali-cel was published in The Lancet Haematology in April 2025 under the digital object identifier 10.1016/S2352-3026(24)00377-6.

CAR-T therapy in the United States and Europe is priced in the high hundreds of thousands of dollars and concentrated in a small number of academic centres. The significance the authors claim for the Indian programme is the demonstration that a domestically manufactured product can be delivered at national scale on a predictable timeline. They conclude that the findings "demonstrate the successful implementation of tali-cel across multiple centers in a large cohort, which might contribute towards improving CAR-T access globally".