嵌合抗原受体T细胞治疗产品临床应用流程管理探讨

Discussion on clinical application process management of chimeric antigen receptor T cell therapy products

近年来我国已批准多个嵌合抗原受体T细胞(chimeric antigen receptor T cell,CAR-T)治疗产品上市,但在其临床准入环节和临床应用流程的管理方面,目前还未达成共识。本文基于细胞治疗临床应用管理经验,结合国内外CAR-T治疗产品临床应用管理现状及相关研究进展,从患者细胞采集和CAR-T的运输、复苏、回输等多个环节对CAR-T治疗产品临床应用管理情况进行总结,探讨CAR-T治疗临床全流程管理及监管措施,为CAR-T治疗产品全生命周期管理提供参考。

Several products of chimeric antigen receptor T cell(CAR-T)therapy have been approved for the market in China in recent years,but there is still no consensus on the management of their clinical access and clinical application process.Based on the experience of clinical application management of cell therapy,combined with the present situation and relevant research progress at home and abroad,we summarize the multiple aspects of patient cell collection,CAR-T transportation,resuscitation and transfusion and discuss the clinical whole process management and regulatory measures of CAR-T therapy so as to provide reference for the whole life cycle management of CAR-T therapy.