CELL INTELLIGENCE · 肿瘤细胞治疗研究

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抗 BCMA CAR-T 细胞免疫治疗复发/难治性多发性骨髓瘤

英文原题：Anti‑BCMA CAR‑T cell immunotherapy for relapsed or refractory multiple myeloma.

查看英文原题

Anti‑BCMA CAR‑T cell immunotherapy for relapsed or refractory multiple myeloma.

PubMed 2023/08/17（内容时间） Exp Ther Med Q3 · IF 2.2（JCR 2025）

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靶点：BCMA技术：CAR-T多发性骨髓瘤地区：中国
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中文摘要

本研究旨在评估抗 B 细胞成熟抗原（BCMA）CAR-T（CAR-T）细胞疗法治疗复发/难治性多发性骨髓瘤的疗效和不良反应。根据细胞治疗浓度将患者分为 3 个剂量组。10 例复发/难治性多发性骨髓瘤患者接受 CAR-T 治疗后，研究对其进行定期监测和评估，以观察疗效及不良反应。中位随访 337 天（253–504 天）时，1 例患者因疾病快速进展于第 24 天死亡。其余 9 例患者的总缓解率为 88.9%，其中 77.8%（7/9）达到微小残留病阴性完全缓解（CR），11.1%（1/9）达到部分缓解。3 例患者维持缓解状态超过 1 年，8 例超过 6 个月。在 3 例发生髓外侵犯的患者中，2 例髓外病灶消失，1 例病灶稳定。

7 例达到 CR 的患者中，CAR-T 细胞拷贝数最高值均 >1×10⁵ copies/μg gDNA；CAR-T 细胞拷贝数达到 1×10⁵ copies/μg 基因组 DNA 后 30 天内（7–30 天）可达到最佳治疗效果。9 例患者的中位起效时间为 43 天（22–169 天），中位无进展生存期为 337 天（253–504 天）。10 例患者中 9 例（90%）出现细胞因子释放综合征，均低于 II 级。另有 9 例（90%）出现血液学不良反应：6 例（60%）严重贫血，5 例（50%）III 级及以上白细胞减少，5 例（50%）粒细胞减少，4 例（40%）III 级及以上血小板减少，3 例（30%）III 级及以上全血细胞减少。研究认为，抗 BCMA CAR-T 细胞疗法是治疗复发/难治性多发性骨髓瘤及髓外侵犯的一种有前景的方法，疗效稳定，不良反应可控。

展开英文摘要原文

The present study aimed to study the efficacy and adverse effects of anti-B-cell maturation antigen (BCMA) chimeric antigen receptor T (CAR-T) cell therapy in relapsed or refractory multiple myeloma. Patients were divided into three dose groups based on cell therapy concentration. After CAR-T cell therapy for 10 patients with recurrent or refractory multiple myeloma, the patients were monitored and evaluated regularly to observe the efficacy and adverse reactions of CAR-T cell therapy. At a median follow-up of 337 (253-504) days, one patient succumbed 24 days due to rapidly progressing disease. The overall response rate of nine patients was 88. 9%, including 77. 8% (7/9) with minimal residual disease negative complete remission (CR) and 11. 1% (1/9) with partial remission. A total of three patients were maintained in remission state for more than a year and eight were maintained for more than six months. Among the three patients with extramedullary invasion, two extramedullary lesions disappeared and one was stable.

The highest copy number of CAR-T cells in seven patients with CR was >1x10 5 copies/ l gDNA, and the best therapeutic effect can be achieved within 30 (7-30) days after the copy number of CAR-T cells reached 1x10 5 copies/ l genomic DNA. The median onset time in the nine patients was 43 (22-169) days, and the median progression-free survival was 337 (253-504). Among the 10 patients, nine (90%) had cytokine release syndrome, all of which were below grade II.

There were nine (90%) patients with hematological adverse reactions, six (60%) patients with severe anemia, five (50%) patients with grade III and above leukopenia, five (50%) patients with granulocytopenia, four (40%) patients with grade III and above thrombocytopenia, and three (30%) patients with grade III and above pancytopenia. It was concluded that anti-BCMA CAR-T cell therapy is a promising treatment method for relapsed or refractory multiple myeloma and extramedullary invasion, with stable efficacy and controllable adverse effects.

论文信息

作者
Zhang X、Ouyang C、Sun G、Liu H、Qi J、Suo X
单位
Department of Hematology, Handan Central Hospital, Handan, Hebei 056001, P.R. China.China
期刊
Experimental and therapeutic medicine2023 Oct
原文标识
PubMed 37664681　·　DOI 10.3892/etm.2023.12170

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