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针对复发/耐药多发性骨髓瘤的BCMA和CD19的双特异性CAR T细胞疗法:一期I/II期试验
Ming Shi1, Jiaojiao Wang2, Hongming Huang3
1Cancer Institute, Xuzhou Medical University, Xuzhou, 221002, China.
Nature communications
|April 20, 2024
概括
针对BCMA和CD19的双特异性BC19仿真抗原受体 (CAR) T细胞在复发性/耐药性多发性髓瘤中显示出有希望的安全性和有效性. 这种双重向的方法为那些对单一向免疫疗法的治疗反应有限的患者提供了新的治疗选择.
科学领域:
- 免疫治疗是一种免疫疗法.
- 在瘤学瘤学.
- 细胞疗法细胞疗法
背景情况:
- 针对多发性骨髓瘤的单向嵌合抗原受体 (CAR) T 细胞疗法面临着初级耐药性和复发的挑战.
- B细胞成熟抗原 (BCMA) 特定的CAR T细胞疗法显示出高响应率,但局限性仍然存在.
研究的目的:
- 设计和评估针对BCMA和CD19的双特异性BC19CART细胞,以增强抗髓瘤活性.
- 评估BC19 CAR T细胞在复发性和耐火性多发性骨髓瘤 (R/R MM) 患者中的安全性和有效性.
主要方法:
- 开发针对BCMA和CD19的双特异性BC19CART细胞.
- 在体外和体内临床前评估抗髓瘤活性.
- 在50名R/RMM患者中进行I/II期临床试验 (ChiCTR2000033567),评估安全性和疗效的终点.
主要成果:
- 在临床前模型中,BC19 CAR T 细胞表现出特定的抗原识别和选择性杀死癌细胞.
- 临床试验达到其主要安全性终点:BC19 CAR T细胞耐受性良好,严重细胞因子释放综合征 (8%) 和神经毒性 (4%) 发病率低.
- 二级终点显示高疗效:92%的整体应答率,中位数无进展生存时间为19.7个月,中位数整体生存时间为19.7个月.
结论:
- 双特异性BC19 CAR T细胞是复发性和耐火性多发性髓瘤患者的可行,安全和有效的治疗选择.
- 用CAR-T细胞对BCMA和CD19进行双重向,克服了单一向疗法的局限性.
- 这种方法对改善R/RMM患者的治疗结果具有显著的前景.
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