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在复发性或耐火性多发性骨髓瘤患者中使用Equecabtagene Autoleucel:FUMANBA-1非随机临床试验
Chunrui Li1,2,3, Keshu Zhou4, Yongxian Hu5
1Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
JAMA oncology
|November 7, 2024
概括
在复发性或耐火性多发性骨髓瘤 (RRMM) 中,Equecabtagene自细胞 (eque-cel) 显示出高响应率. 这种CAR T细胞疗法提供了深度,持久的反应,具有可管理的安全性,即使在以前接受过CAR T细胞治疗的患者中.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 细胞疗法细胞疗法
背景情况:
- 复发性或耐火性多发性骨髓瘤 (RRMM) 呈现出显著的未满足需求.
- 针对B细胞成熟抗原 (BCMA) 向化学抗原受体 (CAR) 的T细胞疗法正在成为一个有前途的治疗方式.
研究的目的:
- 评估equecabtagene autoleucel (eque-cel) 在RRMM患者的疗效和安全性.
- 为了确定整体反应率 (ORR) 和输注后反应的持续时间.
主要方法:
- 一个单臂,开放标签,阶段1b/2试验 (FUMANBA-1) 涉及严重预治疗RRMM的成年患者.
- 患者在淋巴切除后接受了一次同细胞输注 (1.0 × 10^6 CAR-阳性T细胞/kg).
- 数据分析时间为2020年4月至2022年9月,至少追踪时间为15年.
主要成果:
- 在101名可评估患者中观察到总体响应率 (ORR) 为96.0%,其中74.3%的患者实现了完全响应或更好.
- 没有达到中位数无进展生存期;12个月PFS率为78.8%.
- 95.0%的患者获得了最小残留疾病 (MRD) 的负面影响. 细胞因子释放综合征 (CRS) 和免疫效应细胞相关的神经毒性综合征 (ICANS) 一般是低级且可控的.
结论:
- Equecabtagene自细胞 (eque-cel) 显示出显著的疗效,在RRMM患者中诱导早期,深度和持久的反应.
- 该疗法具有良好的安全性,可控的CRS和ICANS.
- Eque-cel是RRMM的潜在治疗选择,包括在以前接触过CAR T细胞的患者中.
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