relmacabtagene autoleucel（一种抗 CD19CAR-T 细胞）治疗复发/难治性 B 细胞非霍奇金淋巴瘤的疗效和安全性：1 期试验的 2 年结果

This study reported 2-year efficacy and safety of relma-cel in Chinese patients with relapsed/refractory (R/R) B-cell non-Hodgkin's lymphoma (B-NHL). In this phase 1 dose-escalating trial, patients received lymphodepleting chemotherapy for 3 days, followed by relma-cel as a single infusion in escalating dose levels (25 10 6 , 50 10 6 , 100 10 6 , and 150 10 6 CAR-T cells). The endpoints included best objective response rate (ORR), best complete response rate (CRR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. A total of 23 patients were enrolled, including 60. 9% with diffuse large B-cell lymphoma and 26. 1% with follicular lymphoma.

Twenty patients were evaluable for efficacy, and the best ORR was 85. 0% and the best CRR was 75. 0%. With a median follow-up of 24. 2 months, 6 patients died and 2 had progressive disease, the median DOR, PFS, and OS were all not reached. The 2-year PFS and OS rates were 60. 0% and 70. 0%, respectively.

Any grade and grade 2 cytokine release syndrome occurred in 18. 2% and 13. 6% of patients, respectively. Only 1(4. 5%) patient had grade 3 CRS lasting 13 days, which was resolved by tocilizumab. No grade 2 neurotoxicity events or treatment-related deaths occurred. Patients with R/R B-NHL treated with relma-cel achieved durable response with favorable safety profile.