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全人源 CAR-T 疗法 CT103A 治疗复发/难治性多发性骨髓瘤的长期安全性与疗效

英文原题:Long-term safety and efficacy of the fully human CAR-T therapy CT103A in relapsed/refractory multiple myeloma.

查看英文原题

Long-term safety and efficacy of the fully human CAR-T therapy CT103A in relapsed/refractory multiple myeloma.

PubMed 2024/11/08(内容时间) Mol Ther Q1 · IF 11.4(JCR 2025)

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中文摘要

CT103A是一种全人源CAR-T 细胞产品,靶向B细胞成熟抗原。本研究报告长期随访后CT103A治疗复发/难治性多发性骨髓瘤(RRMM)患者的更新安全性和疗效数据。截至2023年7月31日,CAR-T 细胞输注后的中位随访时间为45.0个月(范围0.7至58.3个月)。长期随访期间,不良事件发生率随时间逐渐下降。1例患者的缓解持续时间最长,接近5年。全部18例患者(100%)均达到部分缓解或更佳疗效;其中14例(77.8%)最终达到完全缓解或严格完全缓解(sCR),且缓解率随时间增加。数据截止时,9例患者仍存活,其中7例处于微小残留病阴性的sCR状态。全体18例患者的PFS中位数为22.6个月,OS中位数为50.2个月。CAR转基因持续存在的中位时间为14.0个月(范围0.7至57.3个月)。长期随访显示,CT103A凭借持续存在的全人源CAR-T 细胞,可为RRMM患者带来持久临床获益。

展开英文摘要原文

CT103A is a fully human chimeric antigen receptor T cell (CAR-T) product for targeting B cell maturation antigen.

This study presents the updated safety and efficacy profiles of CT103A in patients with relapsed/refractory multiple myeloma (RRMM) after long-term follow-up. As of July 31, 2023, the median follow-up time after CAR-T cell infusion was 45. 0 months (range, 0. 7-58. 3 months). During long-term follow-up, the incidence of adverse events gradually decreased over time. One patient had a maximum duration of response of nearly 5 years. All 18 patients (100%) achieved partial remission or better; 77.

8% (14 of 18) of patients eventually exhibited complete response or stringent complete response (sCR), with response increasing over time. At the time of data cutoff, nine patients were still alive and seven patients had an sCR status with negative minimal residual disease. The median progression-free survival was 22.

6 months, and the median overall survival was 50. 2 months for all 18 patients. The median CAR transgene persistence was 14. 0 months (range, 0. 7-57. 3 months). Long-term follow-up demonstrated that CT103A confers durable clinical benefit for RRMM patients based on the sustained presence of fully human CAR-T cells.

论文信息

作者
Yu Q、Wang D、Li Z、An N、Li C、Bao Y、Wen X、Long X
第一作者单位
Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.China
通讯作者单位
Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China; Key Laboratory of Vascular Aging, Ministry of Education, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China; Immunotherapy Research Center for Hematologic Diseases of Hubei Province, Wuhan, Hubei 430030, China. Electronic address: cunrui5650@hust.edu.cn.China
期刊
Molecular therapy : the journal of the American Society of Gene Therapy2025 Jun 4
原文标识
PubMed 39520053 · DOI 10.1016/j.ymthe.2024.11.013