Talicabtagene autoleucel (NexCAR19™) is a chimeric antigen receptor (CAR) T-cell therapy being developed by the Indian Institute of Technology, Bombay (IIT-B) and Immunoadoptive Cell Therapy (ImmunoACT) for the treatment of relapsed/refractory B-cell malignancies. Talicabtagene autoleucel contains autologous T cells from the patient, which have been modified to express a humanized anti-CD19 CAR that targets B cells. A single intravenous dose of talicabtagene autoleucel was associated with high response rates in pooled results from a phase I and phase II trial in patients with relapsed/refractory B-cell malignancies. Talicabtagene autoleucel was approved in India for the treatment of relapsed/refractory B-cell lymphomas and relapsed/refractory B-cell acute lymphoblastic leukaemia on 13 October 2023. This article summarizes the milestones in the development of talicabtagene autoleucel leading to this first approval for relapsed/refractory B-cell lymphomas and relapsed/refractory B-cell acute lymphoblastic leukaemia.
Keyphrases
- cell therapy
- acute lymphoblastic leukemia
- acute myeloid leukemia
- multiple myeloma
- hodgkin lymphoma
- diffuse large b cell lymphoma
- stem cells
- mesenchymal stem cells
- liver failure
- respiratory failure
- bone marrow
- low dose
- randomized controlled trial
- clinical trial
- high dose
- intensive care unit
- extracorporeal membrane oxygenation
- combination therapy
- replacement therapy
- acute respiratory distress syndrome
- placebo controlled