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
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.
chimeric antigen receptor T cellB-cell receptor-related protein CD19cell therapyindividual case safety expedited reportsrisk management
国家科技期刊平台
NSTL
万方数据
