Exploring Safety and Effectiveness of QT-219CX Universal CAR-T Therapy Targeting CD19 and BCMA for B-Cell Autoimmune Diseases

What this Trial Is About

This research aims to evaluate the safety, tolerability, and preliminary effectiveness of QT-219CX, a universal allogeneic CAR-T cell therapy targeting CD19 and BCMA, in patients with refractory B-cell-related autoimmune diseases such as systemic lupus erythematosus, multi-drug resistant nephrotic syndrome, IgA nephropathy, systemic sclerosis, and ANCA-associated vasculitis. The study includes an exploratory phase focusing on dose escalation and expansion, designed to identify safe dosage levels and monitor potential toxicities. Participants receive a lymphodepleting conditioning treatment followed by a single intravenous infusion of QT-219CX cells. The research consists of two phases a dose-escalation phase using a standard 33 design to determine dose-limiting toxicities and a dose-expansion phase to further assess safety and response. Following infusion, subjects undergo close monitoring for adverse effects and clinical responses. Throughout the study, participants will be evaluated through laboratory tests, imaging, and clinical assessments at multiple time points including days 28, 60, 90, and 180, with key efficacy assessments at days 90 and 180. Safety monitoring includes watching for cytokine release syndrome, neurotoxicity, graft-versus-host disease, infections, and viral reactivation. Long-term follow-up occurs every three months for up to two years to observe pharmacokinetics, pharmacodynamics, and overall safety, ensuring comprehensive evaluation of treatment impact.

CD19/BCMA UCAR-T for B Cell-Related Autoimmune Disease