含靶向B细胞受体相关蛋白CD19的嵌合抗原受体T细胞治疗产品国内临床试验现状

Status on domestic clinical trials of chimeric antigen receptor T cell therapy products containing B-cell receptor-related protein CD19

近年来,嵌合抗原受体T细胞(CAR-T)治疗产品在血液肿瘤治疗中显示出良好的疗效,在实体瘤和自身免疫性疾病治疗中也有所突破。为深入了解CAR-T产品的临床研发进展,本文主要以国家药品监督管理局药品审评中心药物临床试验登记与信息公示平台为信息来源,重点对国内含靶向B细胞受体相关蛋白CD19的CAR-T细胞治疗产品的临床试验进展进行统计分析,希望能进一步提升CAR-T细胞治疗产品的临床研发质量和效率,强化申办者主体责任意识,及时更新试验信息,以保障临床试验期间受试者的权益。

In recent years,chimeric antigen receptor T cell(CAR-T)therapeutic products have shown good efficacy in the treatment of blood tumors,and breakthroughs have also been made in the treatment of solid tumors and autoimmune diseases.In order to further understand the clinical research and development progress of CAR-T products,this paper mainly uses the drug clinical trial registration and information publication platform of the Center for Drug Evaluation National Medical Products Administration as the information source,and focuses on the statistical analysis of the clinical trial progress of domestic CAR-T cell therapy products containing the targeted B-cell receptor-related protein CD19.It is hoped to further improve the quality and efficiency of clinical research and development of CAR-T cell therapy products,strengthen the sponsor's awareness of main responsibility,and timely update trial information to protect the rights and interests of subjects during clinical trials.