肿瘤细胞治疗研究
英文原题：Zevorcabtagene Autoleucel: First Approval.
Zevorcabtagene Autoleucel: First Approval.
Zevorcabtagene autoleucel () 是一种全人源化靶向 B 细胞成熟抗原（BCMA）的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。
Zevorcabtagene autoleucel 是 CARsgen 正在开发用于治疗多发性骨髓瘤的一种全人源 B 细胞成熟抗原（BCMA）特异性嵌合抗原受体（CAR）T 细胞疗法。该自体 CAR T 细胞由全人源 BCMA 特异性单链可变片段（scFv，25C2）、CD8 铰链区和跨膜结构域、4-1BB 共刺激结构域及 CD3ζ T 细胞活化结构域组成。Zevorcabtagene autoleucel 可识别表达 BCMA 的肿瘤细胞，并诱导选择性毒性作用，从而清除这些细胞。2024 年 2 月，该疗法在中国首次获批，用于既往接受 3 线治疗（包括 1 种蛋白酶体抑制剂和一种免疫调节剂）后疾病进展的成人复发或难治性多发性骨髓瘤患者。Zevorcabtagene autoleucel 在加拿大和美国的临床研究正在进行。本文总结了该疗法研发过程中的重要里程碑，以及其首次获批用于复发或难治性多发性骨髓瘤的历程。
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 CD8 hinge region and transmembrane domain, a 4-1BB costimulatory domain and a CD3- 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.
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