Evaluating PRG-1801 BCMA-targeting CAR-T Cells for Treating Refractory Lupus Nephritis and IgG4-Related Disease

What this Trial Is About

Researchers are studying the safety and effectiveness of PRG-1801, a BCMA-targeting CAR-T cell therapy, in treating patients with refractory lupus nephritis and IgG4-related disease. This early-phase clinical trial aims to find a safe and effective dose of PRG-1801 for these difficult-to-treat autoimmune conditions, providing important information on treatment potential and safety. The study includes two phases a dose exploration phase with three dose levels 35, 100, and 300 million CAR-T cells where groups of 3 to 6 patients will be treated and monitored for dose-limiting toxicities, and a dose extension phase where the safe and effective dose identified is further tested in additional patients with each disease. The treatment involves an infusion of PRG-1801 cells, followed by close evaluation to determine safety and response. Participants will undergo regular assessments for up to 24 months after receiving the infusion. These include monitoring for adverse events, blood tests to measure immune cell changes and disease activity, and disease-specific evaluations such as the SLE Disease Activity Index for lupus nephritis and relapse rates for IgG4-related disease. Researchers will also track pharmacokinetic and pharmacodynamic markers and use questionnaires to assess quality of life and symptoms throughout the study period.

Safety and Efficacy of PRG-1801 for Refractory Lupus Nephritis and IgG4-Related Disease