Study of 4SCAR-T Cell Therapy for Advanced or Metastatic Urothelial Bladder Cancer Evaluating Safety and Survival Outcomes

What this Trial Is About

Researchers are evaluating the safety and effectiveness of 4SCAR-T cell therapy in people with locally advanced or metastatic urothelial bladder cancer UBC who have no other treatment options. This Phase III multicenter study focuses on patients with bladder cancer that has spread or cannot be controlled by standard treatments. The study aims to assess overall survival and side effects after infusion of the experimental 4SCAR-T cells. The study involves two types of genetically modified 4th generation CAR-T cells 4SCAR-PSMA and 4SCAR-FRa. These modified T cells are designed to recognize and kill tumor cells by targeting PSMA and FRa proteins, respectively. Participants will receive infusions of one of these CAR-T cell therapies. The study will evaluate side effects, effective doses, and immune responses over time. During the trial, participants will be monitored for survival over one year and adverse events for three months using standard criteria. Researchers will also track how well the infused CAR-T cells expand and persist in the body and measure immune responses. Participants must meet specific health and disease criteria to join, and their condition will be closely followed with scans and laboratory tests. The study will continue until its planned completion at the end of 2029.

Intervention of Bladder Cancer by CAR-T