Statistical analysis
tumor
TUMOR
This interim analysis was conducted with a data cutoff date of 6 October 2022 and followed the statistical analysis plan. The primary efficacy analysis is defined as the ORR, but PFS, overall survival (OS) and DOR were included as secondary/explorative endpoints. The efficacy analyses were conducted with the modified intent to treat population (that is, any patients who had been treated with a conformant dose of the CAR-T product and who had a baseline and at least one on-treatment/posttreatment tumor assessment). The safety analysis set comprises all patients treated with a CAR-T cell product, while patients in the efficacy analysis set were treated with a conformant CLDN6 CAR-T product (≥1 × 10The rates of binary endpoints such as efficacy variables (ORR and DCR) were calculated by cohort along with the corresponding two-sided 95% confidence intervals using the Clopper–Pearson method.Time-to-event endpoints (DOR and PFS) were analyzed using Kaplan–Meier methodology and censored in accordance with the Food and Drug Administration guidance The median event/survival time in days (including two-sided 95% confidence limits according to Brookmeyer and CrowleyCorrelative analyses are descriptive and exploratory. Data were analyzed and depicted using R programming (v.4.1.2) and GraphPad Prism 9.