Mesothelin-positive Advanced Malignant Solid Tumors Clinical Trial
Official title:
Exploratory Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of UCLM802 (Anti-Mesothelin CAR-T) Cell Injection in Patients With Mesothelin-positive Advanced Malignant Solid Tumors
This is a single-arm, open-label, exploratory clinical study to evaluate the safety, tolerability and preliminary efficacy of UCLM802 (Anti-Mesothelin CAR-T) cell injection in patients with Mesothelin-positive advanced malignant solid tumors.
This study comprises a dose-escalation component and a dose-expansion component. In dose escalation phase, this study will adopt accelerated titration and 3+3 design to reduce the number of subjects exposed to potentially ineffective doses who may not benefit from treatment. In dose expansion phase, there are three cohorts in dose-expansion component. Cohort 1: To explore the effects of different conditioning chemotherapy regimens on safety, tolerability and efficacy; Cohort 2: To explore the effects of different administration modes on safety, tolerability and efficacy; Cohort 3: To explore the effects of combination immune checkpoint inhibitors on safety, tolerability and efficacy. All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by UCLM802 cell injection. ;