嵌合抗原受体T细胞治疗产品的上市后临床研究

Post-marketing study of chimeric antigen receptor T-cell therapy

近年来,嵌合抗原受体T细胞成为药物研发热点之一。目前,已有多个嵌合抗原受体T细胞产品经获益/风险评估后获得国内外药品监管当局的批准,主要用于治疗血液系统肿瘤。上市后研究同样属于药物研发的重要部分,已上市的嵌合抗原受体T细胞产品均被要求开展上市后研究,主要是针对继发肿瘤等长期安全性的随访。本文主要介绍目前获批上市的嵌合抗原受体T细胞产品的上市后临床研究要求和具体情况,为同类产品的研发提供参考。

In recent years,chimeric antigen receptor T cells have become a hot spot in drug research and development.A number of chimeric antigen receptor T cells have been approved by drug regulatory agencies for the treatment of hematological malignancies after benefit-risk assessment.Post-marketing study is an important part of drug development,so all approved chimeric antigen receptor T cells are required to take post-marketing studies mainly including long term follow up.This article mainly introduces post-marketing studies of approved chimeric antigen receptor T cell products,providing a reference for the research and development of similar products.