Pharmacokinetics
Characterization of the pharmacokinetics of CLDN6 CAR-T cells was an exploratory endpoint. For lymphodepleted patients at DL1 and DL2, CAR-T cell peak expansion (CARVac was administered to 11 patients who had received CLDN6 CAR-T cells after LD and two patients who received CAR-T cells without prior LD (Extended Data Fig. Given the limited sample size, the heterogeneity of patients and unequal initial engraftment within the subgroups at DL2, the impact of CARVac on persistence of CAR-T cells cannot be statistically evaluated with the data available at this initial cutoff. However, we noted a transient increase in CAR-T cells immediately following CARVac administration in some patients (Extended Data Fig. Further analysis with a larger patient cohort treated with CARVac at an earlier time point is planned to provide a more conclusive understanding of the impact of CARVac on CAR-T cell dynamics.