Abstract：
Zevorcabtagene autoleucel () is a fully humanised B cell maturation antigen (BCMA)-targeting specific chimeric antigen receptor (CAR) T-cell therapy being developed by CARsgen for the treatment of multiple myeloma. Zevorcabtagene autoleucel is an autologous CAR T cell comprising a fully human BCMA-specific scFv (25C2), a CD8α hinge region and transmembrane domain, a 4-1BB costimulatory domain and a CD3-ζ T cell activation domain. Zevorcabtagene autoleucel recognizes and induces selective toxicity against BCMA-expressing tumour cells leading to their elimination. In February 2024, zevorcabtagene autoleucel received its first approval in China for the treatment of adults with relapsed or refractory multiple myeloma who have progressed after ≥ 3 prior lines of therapy (including ≥ 1 proteasome inhibitor and an immunomodulatory agent). Clinical studies of zevorcabtagene autoleucel are underway in Canada and the US. This article summarizes the milestones in the development of zevorcabtagene autoleucel leading to this first approval for relapsed or refractory multiple myeloma.
摘要：
Zevorcabtageneautoleucel（）是一种完全人源化的B细胞成熟抗原（BCMA）靶向特异性嵌合抗原受体（CAR）T细胞疗法，由CARsgen开发，用于治疗多发性骨髓瘤。Zevorcabtageneautoleucel是一种自体CART细胞，包含完全人类BCMA特异性scFv（25C2），一个CD8α铰链区和跨膜结构域，4-1BB共刺激结构域和CD3-ζT细胞活化结构域。Zevorcabtageneautoleucel识别并诱导对表达BCMA的肿瘤细胞的选择性毒性，从而导致其消除。2024年2月，zevorcabtageneautoleucel在中国首次获得批准，用于治疗复发或难治性多发性骨髓瘤的成人，这些多发性骨髓瘤在3项先前治疗后进展（包括1种蛋白酶体抑制剂和一种免疫调节剂）。zevorcabtageneautoleucel的临床研究正在加拿大和美国进行。本文总结了zevorcabtageneautoleucel发展的里程碑，导致首次批准复发或难治性多发性骨髓瘤。
