Endpoints and assessments
death, tumor, CRS, encephalopathy, PD
SECONDARY, RECURRENCE, ENCEPHALOPATHY, TUMOR
The primary endpoints of the study were safety and tolerability of CLDN6 CAR-T cells with or without CARVac and identification of the MTD/recommended phase 2 dose. AEs and serious (S)AEs were collected from signing the informed consent form until 90 days after the last administration of the study drug. Key secondary endpoints included the ORR, the DCR and the DOR per RECIST 1.1. DOR was calculated as the time from first occurrence of CR or PR to the first occurrence of PD (recurrence or death from any cause, whichever occurs first). If patients were redosed with CAR-T cells, the time from first PR/CR to first PD was counted. Exploratory endpoints included overall survival and PFS, CLDN6 expression in tumor tissue, serum cytokines and CAR-T cell persistence.Safety and efficacy parameters were reviewed weekly by the SRC. The DLT period was 28 days. Relatedness of AEs was captured for bridging therapy, LD, CAR-T cells and CARVac. CRS was graded according to American Society for Transplantation and Cellular Therapy guidelines, and ICANS was assessed by immune effector cell encephalopathy scoreCLDN6 CAR-T cell frequency in peripheral blood measured by quantitative polymerase chain reaction (qPCR) was used to calculate CAR-T cell counts, AUC and maximal concentration (