BY: Kerri Fitzgerald
The novel chimeric antigen receptor (CAR) T-cell therapy talicabtagene autoleucel induced durable responses in an Indian population with relapsed or refractory B-cell malignancies, offering a potential new treatment option.
Professor Hasmukh Jain, of Tata Memorial Hospital in India, published the findings in The Lancet Haematology.
The open-label, multicenter, phase 1/2 study included 64 patients from six tertiary cancer centers in India. The phase 1 assessment took place at Tata Memorial Hospital and included 14 adults with relapsed or refractory B-cell lymphoma. The phase 2 basket trial was conducted at the remaining five centers and included 50 patients ages 15 years and older with relapsed or refractory B-cell acute lymphoblastic lymphoma (ALL) or B-cell lymphoma. Patients were a median of 44 years, and 77% were male.
No dose-limiting toxicities occurred in phase 1 at talicabtagene autoleucel dose levels of 2×106 to 17×106 cells/kg. Phase 2 used a dose of at least 5×106, as this dose level induced 3 complete responses in phase 1.
The most common grade ≥3 toxicities were:
- Neutropenia (96%)
- Thrombocytopenia (65%)
- Anemia (61%)
- Febrile neutropenia (47%)
Two treatment-related deaths occurred—one due to febrile neutropenia, immune-effector cell associated hemophagocytic lymphohistiocytosis, and septic shock and the second due to pulmonary bleed, multiorgan dysfunction syndrome, and cytokine release syndrome.
Efficacy was assessed in 51 patients (36 with B-cell lymphoma and 15 with B-cell ALL). The overall response rate was 73%.
“This therapy addresses an important unmet need for patients with relapsed or refractory B-cell malignancies in India,” the authors concluded.
Reference
Jain H, Karulkar A, Kalra D, et al. Talicabtagene autoleucel for relapsed or refractory B-cell malignancies: results from an open-label, multicentre, phase 1/2 study. Lancet Haematol. 2025;12(4):e282-e298. doi:10.1016/S2352-3026(24)00377-6
