A Phase I Clinical Trial of CAR-T Cells for Advanced Gynecological Solid Tumors

"The dose-escalation phase is designed with three predefined dose levels, following a 3+3 design and progressing from low to high doses. The 3+3 dose-escalation scheme is as follows: if no dose-limiting toxicity (DLT) occurs in the three subjects at a given dose level during the observation period, the dose will be escalated to the next higher level. If one subject out of the initial three experiences DLT at a dose level, an additional three subjects will be enrolled at that dose level for further DLT observation. The dose level at which no more than one subject out of the final six subjects experiences DLT will be defined as the maximum tolerated dose (MTD)."