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

Simple Summary The development of CAR-T cell clinical trials has accelerated over the last two decades. These trials, collected on Clinicaltrial.gov until 2022, come mainly from the United States (n = 377) and China (n = 636), while Europe (n = 58) remains far behind these two leading countries. The aim of our analysis of clinical trials was to provide an overview of the characteristics of these trials, such as conditions, targets, phase status, and especially, pointing out the nature of the academic or industrial investigator. We have highlighted that poorly developed academic and industrial collaborations in Europe could be one explanation of the delay of Europe to bring a CAR-T cell product to market, compared to the leading countries. Moreover, regulatory and financial differences also come into play. A valorization of the development of these advanced therapy medicinal products as well as the provision of financial support would accelerate the process in Europe. 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.

Automated summary

The development of CAR-T cell clinical trials has greatly advanced in the United States and China, while Europe lags behind. Poorly developed academic and industrial collaborations, as well as regulatory and financial differences, contribute to Europe's delay. Strengthening the development and providing financial support would accelerate the process in Europe.