靶向B细胞成熟抗原的嵌合抗原受体-T细胞疗法治疗中国复发/难治性多发性骨髓瘤患者疗效及安全性的Meta分析

doi:10.12114/j.issn.1007-9572.2024.0518

中国全科医学 ›› 2026, Vol. 29 ›› Issue (14): 1921-1930.DOI: 10.12114/j.issn.1007-9572.2024.0518

• 论著·医学循证 • 上一篇

靶向B细胞成熟抗原的嵌合抗原受体-T细胞疗法治疗中国复发/难治性多发性骨髓瘤患者疗效及安全性的Meta分析

詹立¹, 衡朝阳², 何俍钰³, 赵捷⁴, 陈杰¹, 邢晋山⁵^,^*()

1．646000　四川省泸州市，西南医科大学基础医学院
2．453003　河南省新乡市，河南医药大学第一临床学院
3．510632　广东省广州市，暨南大学基础医学与公共卫生学院
4．646000　四川省泸州市，西南医科大学附属中医医院影像科
5．646000　四川省泸州市，西南医科大学附属中医医院神经外科

收稿日期:2024-09-29 修回日期:2024-12-19 出版日期:2026-05-15 发布日期:2026-04-14
通讯作者: 邢晋山
作者贡献：
詹立、邢晋山进行文章的构思与设计，研究的实施与可行性分析；詹立、衡朝阳、何俍钰进行数据收集；何俍钰、赵捷、陈杰进行数据整理；詹立、赵捷进行统计学处理；詹立、衡朝阳进行结果的分析与解释；詹立撰写论文；詹立、何俍钰进行论文的修订；邢晋山对文章整体负责，监督管理。
基金资助:
2024年四川省卫生健康委员会科技项目

Efficacy and Safety of CAR-T Therapy Targeting the B Cell Maturation Antigen on Relapsed/Refractory Multiple Myeloma in Chinese People: a Meta-analysis

ZHAN Li¹, HENG Zhaoyang², HE Liangyu³, ZHAO Jie⁴, CHEN Jie¹, XING Jinshan⁵^,^*()

1. School of Basic Medical Sciences, Southwest Medical University, Luzhou 646000, China
2. First Clinical College, Henan Medical University, Xinxiang 453003, China
3. School of Basic Medicine and Public Health, Jinan University, Guangzhou 510632, China
4. Department of Imaging, the Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University, Luzhou 646000, China
5. Department of Neurosurgery, the Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University, Luzhou 646000, China

Received:2024-09-29 Revised:2024-12-19 Published:2026-05-15 Online:2026-04-14
Contact: XING Jinshan

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摘要/Abstract

摘要： 背景靶向B细胞成熟抗原（BCMA）的嵌合抗原受体（CAR）-T细胞在复发/难治性多发性骨髓瘤（RRMM）的临床研究中显示较好的临床疗效，但目前关于其对中国RRMM患者的疗效与安全性的证据较少。目的探讨靶向BCMA CAR-T细胞治疗中国RRMM患者的安全性及有效性。方法计算机检索PubMed、Web of Science、Embase、中国知网、万方数据知识服务平台、维普网数据库，筛选自建库至2024年5月已发表的关于靶向BCMA CAR-T细胞治疗中国RRMM患者的研究，由2名研究者独立筛选文献、提取资料并对纳入研究进行偏倚风险评价。以疗效指标、安全性指标及预后指标等为主要结局指标，采用Stata 16.0软件进行Meta分析。结果共纳入18项研究，包括690例患者。Meta分析结果显示：靶向BCMA CAR-T细胞治疗RRMM患者的总反应率为86%（95%CI=76%~94%），严格的完全缓解率为67%（95%CI=58%~75%），完全缓解率为54%（95%CI=44%~65%），非常好的部分缓解率为16%（95%CI=8%~24%），部分缓解率为17%（95%CI=13%~22%）。细胞因子释放综合征（CRS）发生率为76%（95%CI=56%~92%），3级及以上CRS发生率为16%（95%CI=8%~26%）。白细胞减少率为91%（95%CI=74%~100%），3级及以上白细胞减少率为70%（95%CI=47%~90%）。中性粒细胞减少率为82%（95%CI=54%~99%），3级及以上中性粒细胞减少率为74%（95%CI=52%~92%）。血小板减少率为81%（95%CI=64%~95%），3级及以上血小板减少率为54%（95%CI=37%~70%）。贫血率为78%（95%CI=44%~99%），3级及以上贫血率为55%（95%CI=38%~70%）。免疫效应细胞相关神经毒性综合征（ICANS）率为13%（95%CI=4%~24%），3级及以上ICANS率为0（95%CI=0~2%）。1年内死亡率为3%（95%CI=1%~7%），2年及以上死亡率为35%（95%CI=10%~66%）。1年内复发或进展率为35%（95%CI=19%~52%），2年及以上复发或进展率为35%（95%CI=18%~54%）。1年内病情稳定率为60%（95%CI=34%~83%）。1年内无进展生存率为52%（95%CI=44%~60%）。6个月内总生存率为90%（95%CI=76%~99%），1年及以上总生存率为74%（95%CI=66%~80%）。结论靶向BCMA CAR-T疗法对中国RRMM患者有效且安全，但是存在纳入研究样本量较少、质量不一等问题，需要进行更大规模的研究和更高质量的随机对照试验进一步验证。

关键词: 复发/难治性多发性骨髓瘤, B细胞成熟抗原, 嵌合抗原受体-T细胞疗法, Meta分析

Abstract:

Background

Chimeric antigen receptor (CAR) -T cell therapy targeting the B cell maturation antigen (BCMA) has shown significant clinical efficacy on treating relapsed/refractory multiple myeloma (RRMM). However, evidence regarding its effectiveness and safety in Chinese population remains limited.

Objective

This study aims to evaluate the efficacy and safety of CAR-T therapy targeting the BCMA in Chinese patients with RRMM through a systematic review and meta-analysis.

Methods

Study on CAR-T therapy targeting the BCMA in Chinese RRMM patients published up to May 2024 were comprehensively searched in the PubMed, Web of Science, Embase, CNKI, Wanfang Data, and VIP databases. Two reviewers independently screened the studies, extracted data, and assessed the risk of bias. Primary outcomes included the indicators associated with the efficacy, safety and prognosis. Meta-analysis was performed using Stata 16.0.

Results

Eighteen studies involving 690 patients were included. The pooled results demonstrated an objective response rate (ORR) of 86% (95%CI=76%-94%) in Chinese patients with RRMM treated with BCMA CAR-T therapy, stringent complete response (CR) rate of 67% (95%CI=58%-75%), CR rate of 54% (95%CI=44%-65%), very good partial response (VGPR) rate of 16% (95%CI=8%-24%), partial response rate of 17% (95%CI=13%-22%). Cytokine release syndrome (CRS) was observed in 76% of patients (95%CI=56%-92%), with grade ≥3 CRS reported in 16% (95%CI=8%-26%) of them. Leukopenia was reported in 91% of patients (95%CI=74%-100%), with grade ≥3 leukopenia occurring in 70% (95%CI=47%-90%) of them. Neutropenia was identified in 82% of patients (95%CI=54%-99%), with grade ≥3 neutropenia occurring in 74% (95%CI=52%-92%) of them. Thrombocytopenia occurred in 81% of patients (95%CI=64%-95%), with grade ≥3 thrombocytopenia occurring in 54% (95%CI=37%-70%) of them. Anemia was observed in 78% of patients (95%CI=44%-99%), with grade ≥3 anemia occurring in 55% (95%CI=38%-70%) of them. Immune effector cell-associated neurotoxicity syndrome (ICANS) was reported in 13% of patients (95%CI=4%-24%), with none grade ≥3 ICANS cases observed (95%CI=0-2%). The 1-year mortality rate was 3% (95%CI=1%-7%), while the ≥2-year mortality rate was 35% (95%CI=10%-66%). The 1-year recurrence/progression rate was 35% (95%CI=19%-52%), and 35% (95%CI=18%-54%) at ≥2 years. The stable disease rate within 1 year was 60% (95%CI=34%-83%). The 1-year progression-free survival (PFS) rate was 52% (95%CI=44%-60%). Additionally, the 6-month overall survival (OS) rate was 90% (95%CI=76%-99%) and the ≥1-year OS rate was 74% (95%CI=66%-80%).

Conclusion

CAR-T therapy targeting the BCMA has demonstrated promising efficacy and safety in Chinese patients with RRMM. However, the current studies are limited by small sample sizes and variable quality. Larger-scale and higher-quality randomized controlled trials are needed to further validate its clinical value.

Key words: Relapsed/refractory multiple myeloma, B cell maturation antigen, Chimeric antigen receptor-T cells therapy, Meta-analysis

中图分类号:

R 733.3

詹立,衡朝阳,何俍钰,等. 靶向B细胞成熟抗原的嵌合抗原受体-T细胞疗法治疗中国复发/难治性多发性骨髓瘤患者疗效及安全性的Meta分析[J]. 中国全科医学, 2026, 29(14): 1921-1930. DOI: 10.12114/j.issn.1007-9572.2024.0518.
ZHAN Li,HENG Zhaoyang,HE Liangyu, et al. Efficacy and Safety of CAR-T Therapy Targeting the B Cell Maturation Antigen on Relapsed/Refractory Multiple Myeloma in Chinese People: a Meta-analysis[J]. Chinese General Practice, 2026, 29(14): 1921-1930. DOI: 10.12114/j.issn.1007-9572.2024.0518.

图/表 16

图1 文献筛选流程图

Figure 1 A flow chart of the literature screening

表1 纳入研究的基本特征

Table 1 Basic characteristics of the included studies

第一作者	发表年份（年）	年龄（岁）	性别（男/女）	样本量（例）	中位PFS	中位OS	疗效指标	安全性指标	预后指标	MINORS量表评分（分）
ZHANG^[9]	2023	54（36，73）	6/4	10	11.2个月	—	①②⑤⑥	⑨⑩⑪⑫⑬	⑮⑰⑲	13
ZHANG^[13]	2023	60（16，84）	62/43	105	14.7个月	39.8个月	③④⑤	⑨	⑱⑲	12
LI^[14]	2022	58.85	7/14	21	—	—	—	⑨⑩⑫⑬⑭	⑦⑧⑮	12
QUE^[15]	2021	53（34，69）	23/13	36	12个月	85.3个月	①	⑨⑩⑪⑫⑬	⑦⑱⑲	12
WANG^[16]	2024	54（50，72）	—	7	22.4个月	—	①②③④	⑨⑩⑪⑬⑭	⑯⑲	12
WANG^[17]	2022	57（53，69）	3/1	4	—	—	③⑤	⑨⑩⑫⑬	⑮⑯	13
YANG^[18]	2022	60（39，70）	13/11	24	18.8个月	—	①②③	⑨⑩⑪⑫⑬	⑮⑯⑰⑲	11
ZHOU^[29]	2023	57.5（41，72）	45/23	68	—	—	—	⑨	⑮⑯	12
XU^[19]	2019	—	—	17	—	—	①②④	⑨	⑦⑧ ⑮⑯	12
LI^[20]	2021	55（34，65）	17/13	30	5.3个月	14.2个月	①③	⑨⑩⑪⑫⑬⑭	⑮⑰⑱⑲	12
DENG^[21]	2021	58（42，77）	8/5	13	—	—	①②③④⑤⑥	⑨⑭	⑦⑧⑮	12
张筱媛^[22]	2022	55（43，69）	12/9	21	7.9个月	19.4个月	②③④⑤	⑨	⑮⑯⑱⑲	13
WANG^[23]	2023	59（16，75）	54/39	93	—	—	①③	⑨⑪⑫⑬	⑮	12
SHAO^[24]	2021	61（41，75）	26/11	37	—	—	③④⑤	⑨⑫⑭	⑮	11
DU^[25]	2022	57（37，75）	26/23	49	10个月	29个月	①③	⑨⑩⑪⑫⑬	⑦⑧⑯⑱⑲	13
WANG^[26]	2021	55（27，70）	27/13	40	36.5个月	—	②④⑤	⑨⑭	⑲	11
LIU^[27]	2024	45	26/28	54	25.9个月	47.2个月	①③④⑤	⑨	⑦⑮⑲	12
ZHANG^[28]	2021	—	—	61	21.5个月	—	①③	⑨⑭	⑧⑮⑯	12

图2 靶向BCMA CAR-T细胞治疗RRMM患者ORR的森林图

Figure 2 Forest plots of ORR rate in CAR-T therapy targeting the BCMA for RRMM patients

图3 靶向BCMA CAR-T细胞治疗RRMM患者CR的森林图

Figure 3 Forest plots of CR rate in CAR-T therapy targeting the BCMA for RRMM patients

图4 靶向BCMA CAR-T细胞治疗RRMM患者PR的森林图

Figure 4 Forest plots of PR rates in CAR-T therapy targeting the BCMA for RRMM patients

图5 靶向BCMA CAR-T细胞治疗RRMM患者ORR的敏感性分析

Figure 5 Sensitivity analysis of ORR in CAR-T therapy targeting the BCMA for RRMM patients

图6 靶向BCMA CAR-T细胞治疗RRMM患者VGPR的敏感性分析

Figure 6 Sensitivity analysis of VGPR in CAR-T therapy targeting the BCMA for RRMM patients

图7 靶向BCMA CAR-T细胞治疗RRMM患者CR的敏感性分析

Figure 7 Sensitivity analysis of CR in CAR-T therapy targeting the BCMA for RRMM patients

图8 靶向BCMA CAR-T细胞治疗RRMM患者CRS率的森林图

Figure 8 Forest plots of CRS rates in CAR-T therapy targeting the BCMA for RRMM patients

图9 靶向BCMA CAR-T细胞治疗RRMM患者血小板减少率的森林图

Figure 9 Forest plots of thrombocytopenia rates in CAR-T therapy targeting the BCMA for RRMM patients

图10 靶向BCMA CAR-T细胞治疗RRMM患者贫血率的森林图

Figure 10 Forest plots of anemia rates in CAR-T therapy targeting the BCMA for RRMM patients

图11 靶向BCMA CAR-T治疗RRMM患者1年内死亡率的森林图

Figure 11 Forest plots of 1-year mortality in CAR-T therapy targeting the BCMA for RRMM patients

图12 靶向BCMA CAR-T治疗RRMM患者1年及以上总生存率的森林图

Figure 12 Forest plots of 1 year and above of OS rates in CAR-T therapy targeting the BCMA for RRMM patients

图13 靶向BCMA CAR-T细胞治疗RRMM患者ORR漏斗图

Figure 13 Funnel plots of ORR in CAR-T therapy targeting the BCMA for RRMM patients

图14 靶向BCMA CAR-T细胞治疗RRMM患者CR漏斗图

Figure 14 Funnel plots of CR in CAR-T therapy targeting the BCMA for RRMM patients

图15 靶向BCMA CAR-T细胞治疗RRMM患者CRS漏斗图

Figure 15 Funnel plots of CRS in CAR-T therapy targeting the BCMA for RRMM patients

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靶向B细胞成熟抗原的嵌合抗原受体-T细胞疗法治疗中国复发/难治性多发性骨髓瘤患者疗效及安全性的Meta分析

Efficacy and Safety of CAR-T Therapy Targeting the B Cell Maturation Antigen on Relapsed/Refractory Multiple Myeloma in Chinese People: a Meta-analysis

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