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在复发/耐药多发性骨髓瘤中对HBI0101 (BCMA CART) 治疗的临床评估和反应的决定因素

Shlomit Kfir-Erenfeld¹, Nathalie Asherie¹, Eyal Lebel²

¹Department of Bone Marrow Transplantation and Cancer Immunotherapy, Faculty of Medicine, Hadassah Medical Center, Hebrew University of Jerusalem, Jerusalem, Israel.

|May 20, 2024

概括

针对BCMA的化学抗原受体T细胞 (CART) 疗法在复发性/耐药性多发性髓瘤中显示出高响应率. 诸如高风险细胞遗传学和外骨髓性疾病等因素会影响无进展生存率.

科学领域:

血液学血液学血液学
在瘤学瘤学.
免疫治疗是一种免疫疗法.

背景情况:

复发性和耐火性多发性骨髓瘤 (R/RMM) 呈现出显著的未满足需求.
针对B细胞成熟抗原 (BCMA) 向的嵌合抗原受体T细胞 (CART) 疗法提供了一种新的治疗方法.

研究的目的:

为了评估HBI0101的安全性和有效性,BCMA向的CART疗法,在重度预治疗的R/RMM患者中.
确定影响治疗结果的患者和CART相关因素.

主要方法:

一阶段1b/2临床试验,涉及50名R/RMM患者,接受800×10^6CART细胞治疗.
包括标准允许比典型的关键试验更广泛的患者群体.
对毒性,反应率,无进展生存期 (PFS) 和总生存期 (OS) 的分析.

主要成果:

90%的患者获得了反应,56%的患者获得了严格的完全反应.
70%的患者实现了最小的残留疾病负面性.
中位数PFS为11.0个月;没有达到OS. 观察到1-3级细胞因子释放综合征和1-2级神经毒性.

结论:

HBI0101在R/RMM患者中显示出有希望的疗效,包括那些具有不太有利特征的患者.
高风险细胞遗传学,外骨髓性疾病和CART产品成分独立预测了较差的PFS.
进一步分析影响CART治疗反应的因素对于优化患者的治疗结果至关重要.

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