CAR-T（CAR-T）细胞疗法在非肿瘤性疾病中的应用
Chimeric antigen receptor T (CAR-T) cell therapy in non-oncological diseases.
CAR-T（CAR-T）细胞在血液系统恶性肿瘤中的应用推动了这种免疫治疗形式的显著进展。
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
联合抗 BCMA 和抗 CD19 CAR-T 细胞疗法治疗复发/难治性多发性骨髓瘤的临床疗效与安全性：系统综述与荟萃分析
英文原题：Clinical efficacy and safety of combined anti-BCMA and anti-CD19 CAR-T cell therapy for relapsed/refractory multiple myeloma: a systematic review and meta-analysis.
查看英文原题
Clinical efficacy and safety of combined anti-BCMA and anti-CD19 CAR-T cell therapy for relapsed/refractory multiple myeloma: a systematic review and meta-analysis.
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研究概要
作为一种具有巨大潜力的新型免疫治疗策略，抗 BCMA 和抗 CD19 CAR-T 细胞联合疗法在 RRMM 中显示出高疗效，但其安全性需要进一步改善。这项 meta 分析提示联合 CAR-T 疗法可能可以优化。
研究思路结论见上方概要
背景
近期研究中针对复发/难治性多发性骨髓瘤（RRMM）的持久缓解率较低，提示嵌合抗原受体（CAR）-T细胞疗法仍有待优化。联合抗BCMA和抗CD19 CAR-T 细胞疗法在多项RRMM临床试验中显示出较高的临床疗效。我们在此进行了一项meta分析，以确认其疗效和安全性。
方法
我们收集了截至2023年4月的Embase、Web of Science、PubMed、CNKI、万方和Cochrane数据库中的数据。我们提取并评估了与联合抗BCMA和抗CD19 CAR-T 细胞疗法在RRMM患者中的疗效和安全性相关的数据。随后使用RevMan5.4和StataSE-64软件对数据进行了分析。PROSPERO注册号为CRD42023455002。
结果
我们的meta分析纳入了12项相关临床试验，涉及347例接受抗BCMA和抗CD19 CAR-T 细胞联合治疗的RRMM患者。在疗效评估方面，汇总的总体缓解率（ORR）为94%（95% CI：91%-98%），完全缓解率（CRR）为50%（95% CI：29%-71%），缓解者中微小残留病（MRD）阴性率为73%（95% CI：66%-80%）。在安全性方面，汇总的任何级别细胞因子释放综合征（CRS）发生率为98%（95% CI：97%-100%），3级CRS发生率为9%（95% CI：4%-14%），神经毒性发生率为8%（95% CI：4%-11%）。在血液学毒性方面，中性粒细胞减少为82%（95% CI：75%-89%），贫血为71%（95% CI：53%-90%），血小板减少为67%（95% CI：40%-93%），感染为42%（95% CI：9%-76%）。中位无进展生存期（PFS）为12.97个月（95% CI：6.02-19.91），中位总生存期（OS）为26.63个月（95% CI：8.14-45.11）。
展开英文摘要原文
BACKGROUND
The low rates of durable response against relapsed/refractory multiple myeloma (RRMM) in recent studies prompt that chimeric antigen receptor (CAR)-T cell therapies are yet to be optimized. The combined anti-BCMA and anti-CD19 CAR-T cell therapy showed high clinical efficacy in several clinical trials for RRMM. We here conducted a meta-analysis to confirm its efficacy and safety.
METHODS
We collected data from Embase, Web of Science, PubMed, CNKI, Wanfang and Cochrane databases up to April 2023. We extracted and evaluated data related to the efficacy and safety of combined anti-BCMA and anti-CD19 CAR-T cell therapies in RRMM patients. The data was then analyzed using RevMan5.4 and StataSE-64 software. PROSPERO number was CRD42023455002.
RESULTS
Our meta-analysis included 12 relevant clinical trials involving 347 RRMM patients who were treated with combined anti-BCMA and anti-CD19 CAR-T cell therapies. For efficacy assessment, the pooled overall response rate (ORR) was 94% (95% CI: 91%-98%), the complete response rate (CRR) was 50% (95% CI: 29%-71%), and the minimal residual disease (MRD) negativity rate within responders was 73% (95% CI: 66%-80%). In terms of safety, the pooled all-grade cytokine release syndrome (CRS) rate was 98% (95% CI: 97%-100%), grade 3 CRS rate was 9% (95% CI: 4%-14%), and the incidence of neurotoxicity was 8% (95% CI: 4%-11%). Of hematologic toxicity, neutropenia was 82% (95% CI: 75%-89%), anemia was 71% (95% CI: 53%-90%), thrombocytopenia was 67% (95% CI: 40%-93%) and infection was 42% (95% CI: 9%-76%). The median progression-free survival (PFS) was 12.97 months (95% CI: 6.02-19.91), and the median overall survival (OS) was 26.63 months (95% CI: 8.14-45.11).
CONCLUSIONS
As a novel immunotherapy strategy with great potential, the combined anti-BCMA and anti-CD19 CAR-T cell therapy showed high efficacy in RRMM, but its safety needs further improvement. This meta-analysis suggests possible optimization of combined CAR-T therapy. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/, identifier CRD42023455002.
论文信息
- 作者
- Xu H、Guan C、Xu P、Zhou D、Xu Y、Chen B、Bai H
- 单位
- Department of Hematology, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.China
- 文献类型
- 系统综述
- 期刊
- Frontiers in oncology2024
- 原文标识
- PubMed 38651157 · DOI 10.3389/fonc.2024.1355643
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