Abstract: Objective To assess the suspected unexpected serious adverse reaction (SUSAR) reports of chimeric antigen receptor T (CAR-T) cells therapy products under clinical trials received by the Center for Drug Evaluation and National Medical Products Administration. Methods The SUSAR individual case safety reports of CAR-T therapy products received between May 1, 2018 and August 31, 2019 were retrieved from the pharmacovigilance database and analyzed retrospectively. Results A total of 73 SUSAR reports of CAR-T cells therapy products were received. An overall increase in the number of SUSAR reports was observed. The percentage of males and females was 54.1% and 45.9%, respectively. Most of the reported SUSARs involved subjects aged 60 to 69 (39.7%). The number of SUSAR reports from China was six (8.2%). The percentage of phase I/II clinical trials was the highest (43.8%). The percentage of grade 3 or above was 69.6%. Nervous system disorders, general disorders and administration site conditions were among the most commonly reported system organ class (SOC). The percentage of CRS and CRES was 39.6% and 23.3% respectively. Thirteen cases of death were identified in the pharmacovigilance database. Progression of cancer and severe infections were the main causes of death. Conclusion Sponsors should establish pharmacovigilance systems, submit reports of SUSARs as scheduled, and improve the quality of reports. In addition, regulators are expected to monitor and evaluate SUSARs to ensure the safety of subjects during clinical trials.

Key words: chimeric antigen receptor T cell, suspected unexpected serious adverse reaction, pharmacovigilance, safety