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截至 2022 年 CAR-T 细胞临床试验系统综述:学术中心的贡献

英文原题:Systematic Review on CAR-T Cell Clinical Trials Up to 2022: Academic Center Input.

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Systematic Review on CAR-T Cell Clinical Trials Up to 2022: Academic Center Input.

PubMed 2023/02/04(内容时间) Cancers (Basel) Q2 · IF 4.8(JCR 2025)

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中文摘要

CAR-T 细胞疗法的开发最初由美国和中国推动,目前临床试验数量仍由这两个国家领先;欧洲启动首批相关试验较晚。在本系统综述中,我们旨在概述全球临床试验中CAR-T 细胞的制备情况,并探讨欧洲进展滞后的原因。我们特别关注处于该疗法研发核心位置的学术中心。截至2023年1月25日,我们在ClinicalTrials.gov统计到1,087项CAR-T 细胞临床试验(研究注册编号:reviewregistry1542)。研究先进行全球分析,再分析58项欧洲试验,其中34项由学术中心发起。学术机构与产业界合作似乎是CAR-T 细胞成功开发并获得上市许可所必需的;与领先国家相比,这种合作在欧洲试验中仍严重不足。欧洲目前仍远落后于两个领先国家,正试图通过放宽先进治疗药品(ATMP)相关监管并增加资金支持,鼓励开展涉及此类疗法的临床试验。

展开英文摘要原文

The development of Chimeric Antigen Receptor T cells therapy initiated by the United States and China is still currently led by these two countries with a high number of clinical trials, with Europe lagging in launching its first trials. In this systematic review, we wanted to establish an overview of the production of CAR-T cells in clinical trials around the world, and to understand the causes of this delay in Europe.

We particularly focused on the academic centers that are at the heart of research and development of this therapy.

We counted 1087 CAR-T cells clinical trials on ClinicalTrials. gov (Research registry ID: reviewregistry1542) on the date of 25 January 2023.

We performed a global analysis, before analyzing the 58 European trials, 34 of which sponsored by academic centers. Collaboration between an academic and an industrial player seems to be necessary for the successful development and application for marketing authorization of a CAR-T cell, and this collaboration is still cruelly lacking in European trials, unlike in the leading countries.

Europe, still far behind the two leading countries, is trying to establish measures to lighten the regulations surrounding ATMPs and to encourage, through the addition of fundings, clinical trials involving these treatments.

论文信息

作者
Wang V、Gauthier M、Decot V、Reppel L、Bensoussan D
单位
CNRS, Lorraine University, IMoPA, F-54000, Nancy, France.France
文献类型
综述
期刊
Cancers2023 Feb 4
原文标识
PubMed 36831349 · DOI 10.3390/cancers15041003