Phase 1 Study of QT-219C Universal Allogeneic CAR-T Cell Therapy Targeting CD19 and BCMA for Treating B-Cell Autoimmune Diseases

What this Trial Is About

Researchers are evaluating a new cell therapy called QT-219C, a universal allogeneic CAR-T cell product targeting both CD19 and BCMA, for 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. This Phase 1, exploratory, open-label study aims to assess the safety, tolerability, and preliminary effectiveness of QT-219C, focusing on dose-limiting toxicities and clinical responses, with two phases dose escalation and dose expansion. Participants will undergo a lymphodepleting conditioning regimen before receiving a single intravenous infusion of QT-219C cells. The dose-escalation phase uses a standard 33 design to find the recommended dose and observe toxicities. After infusion, subjects are monitored intensively for side effects like cytokine release syndrome and neurotoxicity. Key efficacy assessments occur at Days 28, 60, 90, and 180, followed by a long-term follow-up phase with visits every three months for up to two years. Throughout the study, participants will have baseline labs and imaging, safety monitoring, and evaluations of pharmacokinetics and pharmacodynamics, including CAR-T cell expansion and B-cell depletion. Researchers will track immune responses and disease activity and assess safety over time. The total involvement includes initial screening, treatment, close safety monitoring for 28 days, periodic efficacy checks up to six months, and long-term follow-up for up to two years.

Allogeneic CD19/BCMA CAR-T for B Cell-Related Autoimmune Disease