Analyse 113 cases of chimeric antigen receptor T cell therapy products containing B-cell receptor-related protein CD19 from clinical trials individual case safety expedited reports and risk management
10.13699/j.cnki.1001-6821.2024.18.031
- VernacularTitle:113例含靶向B细胞受体相关蛋白CD19的嵌合抗原受体T细胞治疗产品的临床试验个例安全性快速报告分析及风险管理
- Author:
Min LIU
1
;
Yan CHEN
;
Wen-Ya TANG
;
Feng XUE
;
Hai-Xue WANG
Author Information
1. 国家药品监督管理局药品审评中心,北京 102600
- Keywords:
chimeric antigen receptor T cell;
B-cell receptor-related protein CD19;
cell therapy;
individual case safety expedited reports;
risk management
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(18):2757-2760
- CountryChina
- Language:Chinese
-
Abstract:
The chimeric antigen receptor T cell(CAR-T)therapy products approved for market and under development mainly targets the B-cell receptor-related protein CD19.This paper relies on the pharmacovigilance database during clinical trials of the Center for Drug Evaluation National Medical Products Administration.We retrospectively analyzed the 113 individual case safety expedited reports of suspected unexpected serious adverse reactions of CAR-T cell therapy products containing B-cell receptor-rolated protein CD19 from domestic clinical trials received from January 1,2021 to May 20,2024.Strengthen risk management according to product characteristics.It is expected that through this paper,the sponsors can improve the pharmacovigilance regime and system,timely report according to the requirements,strengthen the risk communication with the regulatory authorities,form a joint force with the regulatory authorities,and jointly do a good job in risk management during clinical trials.
