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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.
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.
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.
Shares Talicabtagene autoleucel, Tata Memorial Centre, Manufacturing cost and time for living and radioactive medicines, Most of the world has almost no cancer care.
Shares Indian Institute of Technology Bombay, ImmunoACT, Talicabtagene autoleucel (NexCAR19) phase 1/2, Talicabtagene autoleucel.
Shares Rahul Purwar, Indian Institute of Technology Bombay, ImmunoACT, Talicabtagene autoleucel (NexCAR19) phase 1/2.
Shares ImmunoACT, Talicabtagene autoleucel, Most of the world has almost no cancer care, CAR-T cell therapy.
Shares Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy, Acute lymphoblastic leukaemia, Diffuse large B-cell lymphoma.
Shares Talicabtagene autoleucel, Manufacturing cost and time for living and radioactive medicines, Most of the world has almost no cancer care, CAR-T cell therapy.
Shares Indian Institute of Technology Bombay, ImmunoACT, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
Shares Manufacturing cost and time for living and radioactive medicines, Most of the world has almost no cancer care, CAR-T cell therapy, Acute lymphoblastic leukaemia.