Wang Valentine, Gauthier Mélanie, Decot Véronique, Reppel Loïc, Bensoussan Danièle
CNRS, Lorraine University, IMoPA, F-54000, Nancy, France.
Cell Therapy and Tissue Bank Unit, CHRU Nancy, F-54000, Nancy, France.
Cancers (Basel). 2023 Feb 4;15(4):1003. doi: 10.3390/cancers15041003.
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.
由美国和中国发起的嵌合抗原受体T细胞（CAR-T）疗法的发展目前仍由这两个国家主导，它们开展了大量临床试验，而欧洲在开展首批试验方面滞后。在这项系统评价中，我们希望对全球临床试验中CAR-T细胞的生产情况进行概述，并了解欧洲出现这种延迟的原因。我们特别关注了处于该疗法研发核心地位的学术中心。在2023年1月25日，我们在ClinicalTrials.gov（研究注册ID：reviewregistry1542）上统计到1087项CAR-T细胞临床试验。在分析58项欧洲试验之前，我们进行了全球分析，其中34项由学术中心赞助。学术机构与产业界参与者之间的合作对于CAR-T细胞成功研发及申请上市许可似乎是必要的，而在欧洲试验中，这种合作仍然严重缺乏，这与领先国家不同。欧洲仍远远落后于两个领先国家，正试图制定措施以放宽围绕先进治疗药品（ATMPs）的法规，并通过增加资金投入来鼓励开展涉及这些治疗方法的临床试验。
