Phase 2 study of relmacabtagene autoleucel (CD19 CAR-T) for relapsed/refractory mantle cell lymphoma in Chinese adults

作者：Yan Xie, Keshu Zhou, Lanfang Li, Aibin Liang, Heng Mei, Dehui Zou, Wenyu Li, Jie Jin, Zhengming Jin, Hongmei Jing, Haiyan Yang, Tong Chen, Huiqiang Huang, Pengcheng He, Junning Cao, Zhen Xia, Yongen Gu, Yi-Bei Zang, Zi-Song Zhou, Zhao-Zhao Tian, Jun Zhu, Yu-Qin Song · 发表于：Blood Advances · 年份：2025 · DOI：10.1182/bloodadvances.2024015763 · 被引用次数：5 · 研究领域：CAR-T cell therapy research、Integrated Circuits and Semiconductor Failure Analysis、Lymphoma Diagnosis and Treatment

ABSTRACT: Relmacabtagene autoleucel (relma-cel), an anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, is approved in China for relapsed/refractory (R/R) large B-cell lymphoma and follicular lymphoma. This phase 2, open-label, single-arm, multicenter study evaluated its efficacy and safety in Chinese patients with heavily pretreated R/R mantle cell lymphoma (MCL). A total of 70 patients with R/R MCL who had received 1 to 9 previous therapies (including anthracycline or bendamustine chemotherapy, anti-CD20 antibodies, and Bruton tyrosine kinase [BTK] inhibitors) were enrolled. Of these, 59 received a single infusion of 100 × 106 CAR-positive T cells following leukapheresis. The primary end point was the objective response rate (ORR) at 3 months after infusion, assessed using the Lugano 2014 criteria. Secondary end points included the duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. At 3 months, the ORR was 71.19% (95% confidence interval [CI], 57.92-82.24) with a complete response rate of 59.32% (95% CI, 45.75-71.93). After a median follow-up of 13.3 months (95% CI, 9.04-18.69), the median DOR was 18.1 months, PFS was 15.5 months, and OS was 19.5 months. Grade 3 or higher treatment-emergent adverse events were common, including neutropenia (76.3%), leukopenia (69.5%), and lymphopenia (47.5%). Severe cytokine release syndrome and neurotoxicity occurred in 6.8% of patients each, and all cases resolved fully. No fatal events...