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双特异的CS1-BCMA CAR-T细胞在复发性或耐火性多发性髓瘤中具有临床活性
Chenggong Li1,2, Jia Xu1,2, Wenjing Luo1,2
1Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.
Leukemia
|October 17, 2023
概括
双特异的CS1-BCMA CAR-T细胞对复发性或耐火性多发性髓瘤 (MM) 显示出前景. 这种疗法显示出高响应率和良好的安全性,CAR-T细胞长期存在.
科学领域:
- 免疫治疗是一种免疫疗法.
- 在瘤学瘤学.
- 血液学 血液学 血液学
背景情况:
- 多发性骨髓瘤 (MM) 表现出细胞异质性,使单一向免疫疗法复杂化.
- 双特异性CAR-T细胞提供了一种潜在的策略,通过向多个抗原来克服治疗耐药性.
研究的目的:
- 评估双特异性CS1-BCMA CAR-T细胞在复发性或耐火性多发性髓瘤 (RRMM) 患者中的安全性和有效性.
主要方法:
- 一个I期临床试验,涉及16名RRMM患者,他们接受了CS1-BCMA CAR-T细胞输液.
- 监测不良事件,反应率,最小残留疾病 (MRD) 负面影响,总生存率 (OS) 和无进展生存率 (PFS).
- 探索耐药性机制,包括单独的外骨髓性疾病 (sEMD),并评估CAR-T细胞持久性和可溶性BCMA作为生物标志物.
主要成果:
- 观察到的整体响应率为81%,其中38%达到严格的完整响应 (sCR).
- 常见的不良事件包括血液毒性;细胞因子释放综合征 (CRS) 在38%的患者中发生 (31%的1-2级),没有神经毒性.
- 卡特-T细胞持续平均406天,可溶性BCMA显示出作为疗效生物标志物的潜力. 四名患者复发了BCMA+和CS1+疾病.
结论:
- 在RRMM患者中,CS1-BCMA CAR-T细胞表现出临床活性和有利的安全性.
- 双特异性方法可以克服阻力机制,尽管sEMD是一个挑战.
- 长期的持久性和MRD负面影响的可能性凸显了这一策略的治疗前景.
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