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一种替代性全人源抗 BCMA CAR-T 对既往接受过抗 BCMA CAR-T 的复发/难治性多发性骨髓瘤显示缓解

英文原题:An alternative fully human anti-BCMA CAR-T shows response for relapsed or refractory multiple myeloma with anti-BCMA CAR-T exposures previously.

PubMed 2023/12/15(内容时间) Cancer Gene Ther Q1 · IF 6.4(JCR 2025)

研究概要

1-2 级细胞因子释放综合征(CRS)发生于 3 例患者(42.9%),3 级发生于 2 例患者(28.6%)。

中文摘要

CAR-T(CAR-T)细胞疗法在复发/难治性多发性骨髓瘤(R/R MM)治疗中取得显著进展。遗憾的是,即使接受抗BCMA CAR-T治疗,患者最终仍可能出现疾病进展或复发。目前,对于抗BCMA CAR-T治疗后进展的患者,可选治疗方案的数据有限。本研究评估了全人源抗BCMA CAR-T(HRC0202)在7例既往接受过抗BCMA CAR-T治疗的R/R MM患者中的安全性和疗效。3例患者接受6.0×10⁶ CAR+ T细胞/kg,1例接受10.0×10⁶ CAR+ T细胞/kg,3例接受15.0×10⁶ CAR+ T细胞/kg。3例患者(42.9%)发生1–2级细胞因子释放综合征(CRS),2例(28.6%)发生3级CRS。所有患者均未观察到免疫效应细胞相关神经毒性综合征(ICANS)。最佳总体缓解率(ORR)为71.4%(5/7),其中3例达到严格完全缓解/完全缓解(sCR/CR)。无进展生存期(PFS)中位数为269天,所有患者的总生存期(OS)中位数尚未达到。HRC0202的中位峰值浓度(Cmax)为30,117.70拷贝/μg DNA(范围:6,084.35–147,415.10)。本研究提示,对于既往接受抗BCMA CAR-T输注后复发或难治的R/R MM患者,全人源抗BCMA CAR-T(HRC0202)是一种有前景的治疗选择。

展开英文摘要原文

Chimeric antigen receptor T (CAR-T) cells therapy has made remarkable progress in relapsed/refractory multiple myeloma (R/R MM) treatment. Unfortunately, patients still eventually experience disease progression or relapse even after receiving anti-BCMA CAR-T therapy. At present, there are limited data on available treatment options for patients who have progressed on anti-BCMA CAR-T therapy. In this study, we evaluated the safety and efficacy of fully human anti-BCMA CAR-T (HRC0202) in seven R/R MM patients who were previously exposed to anti-BCMA CAR-T therapy. Three patients received 6.0 10 6 CAR + T cells/kg, one patient received 10.0 10 6 CAR + T cells/kg and three patients received 15.0 10 6 CAR + T cells/kg. Cytokine release syndrome (CRS) of grades 1-2 occurred in three patients (42.9%) and grade 3 in two patients (28.6%). Immune effector cell-associated neurotoxic syndrome (ICANS) was not observed in any of the patients. The best overall response rate (ORR) was 71.4% (5/7), with a stringent complete response/complete response (sCR/CR) achieved in three patients. The median progression-free survival (PFS) was 269 days, and median overall survival (OS) for all patients was not reached. The median peak concentration (C max ) of HRC0202 was 30117.70 (range, 6084.35-147415.10) copies/ g DNA. This study indicated that fully human anti-BCMA CAR-T (HRC0202) is a promising treatment for R/R MM patients who relapsed or refractory from prior anti-BCMA CAR-T infusion.

论文信息

作者
Wang Q、Wei R、Guo S、Min C、Zhong X、Huang H、Cheng Z
第一作者单位
Department of Hematology, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China. Ndefy98001@ncu.edu.cn.China
通讯作者单位
Department of Hematology, Henan Province Hospital of Traditional Chinese Medicine (The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine), Institute of Hematology, Henan University of Traditional Chinese Medicine, Zhengzhou, China. chzhi63@163.com.China
文献类型
非美国政府资助研究
期刊
Cancer gene therapy2024 Mar
原文标识
PubMed 38102463 · DOI 10.1038/s41417-023-00712-0