Study of PRG-2311 CAR-T Cell Therapy for Treatment-Resistant Lupus Nephritis and IgG4-Related Disease

What this Trial Is About

Researchers are evaluating the safety and effectiveness of PRG-2311, a type of CD19BCMA-targeting CAR-T cell therapy, for treating people with refractory lupus nephritis and IgG4-related disease. This early phase 1 clinical trial aims to find a safe and effective dose of this new cell therapy for patients who have not responded to standard treatments. The study is sponsored by Tongji Hospital and focuses on these serious immune-related kidney and systemic conditions. The trial has two main parts a dose exploration phase and a dose expansion phase. In the dose exploration phase, participants receive one of three different doses of PRG-2311 to evaluate safety and dose-limiting toxicities. If the dose is found to be safe and effective, the dose expansion phase includes more patients receiving that dose to further assess its safety and effectiveness for lupus nephritis and IgG4-related disease separately. Participants will be closely monitored for up to 24 months after receiving the PRG-2311 infusion. Researchers will measure safety outcomes such as adverse events and dose tolerance, and track changes in disease activity scores, kidney function, relapse rates, and immune system markers. Laboratory tests, blood samples, and patient questionnaires will be collected at multiple timepoints to understand how the treatment affects the diseases and the immune system over time.

Safety and Efficacy of PRG-2311 for Refractory Lupus Nephritis and IgG4-Related Disease