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Talicabtagene autoleucel for patients with R/R B-cell malignancies: Results from a phase I/II trial
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Outcomes for patients with R/R B-cell malignancies in low- and middle-income countries remain poor compared with the rest of the world, with a lack of effective therapies contributing to this disparity.1 Talicabtagene autoleucel (formerly actalycabtagene autoleucel) is a novel, humanized, second-generation, anti-CD19 4-1BB CAR T-cell therapy developed to address these challenges.1 An open-label, multicenter, phase I/II trial assessed the efficacy and safety of talicabtagene autoleucel in patients aged ≥15 years with R/R B-cell ALL (n = 17) or B-cell lymphoma (n = 47) across six centers in India.1 Results from this trial were published in Lancet Haematology by Jain et al.1 |
| Key learnings |
| In the phase I part (n = 14), no DLTs were observed at doses of 2 × 10⁶ – 17 × 10⁶ CAR T-cells per kg. A dose of ≥5 × 10⁶ CAR T-cells per kg was selected as the phase II dose as a result of a CR in 3 out of 7 patients. |
| The phase II primary endpoint was met; the ORR was 73% in the efficacy-evaluable population (B-cell lymphoma, n = 36; B-cell ALL, n = 15), with the median DOR not reached. |
| The most common Grade ≥3 AEs were hematological events, including neutropenia (96%), thrombocytopenia (65%), anemia (61%), and febrile neutropenia (47%). Two treatment-related deaths occurred. |
| Talicabtagene autoleucel demonstrated a manageable safety profile and durable responses in patients with B-cell malignancies, with local manufacturing and a short vein-to-vein time (median 18 days) enabling timely delivery and allowing the potential for this therapy to be viable in low-resource settings. |
Abbreviations: AE, adverse event; ALL, acute lymphoblastic leukemia; CAR, chimeric antigen receptor; CR, complete remission; DLT, dose-limiting toxicity; DOR, duration of response; ORR, overall response rate; R/R, relapsed/refractory.
- 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-e293. DOI: 10.1016/S2352-3026(24)00377-6
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