Early Phase 1 Study Evaluating Safety and Effects of Targeted CD19 or CD19-BCMA CAR-T Therapy in Adults with Autoimmune Diseases Including SLE, Systemic Sclerosis, Vasculitis, Myopathies, and Sjogrens Syndrome

What this Trial Is About

This clinical trial is focused on patients with active autoimmune diseases including Systemic Lupus Erythematosus SLE, Systemic Sclerosis SSc, ANCA Associated Vasculitis AAV, Idiopathic Inflammatory Myopathies IIM, and Sjogrens Syndrome pSS. The study aims to evaluate the safety, tolerability, how the body processes and responds to, and the effectiveness of two types of CAR-T therapies targeting CD19 or CD19-BCMA in these conditions. This early phase 1 trial is sponsored by Nanjing Bioheng Biotech Co., Ltd and involves patients aged between 18 and 70 years. Participants will receive CAR T-cell therapy administered through an intravenous infusion following a lymphodepleting chemotherapy regimen that includes fludarabine and cyclophosphamide. The study includes one experimental treatment group receiving CD19 or CD19-BCMA CAR-T cells. The trial is open-label with no masking or placebo control. During the study, participants will be closely monitored for adverse events related to the treatment over a period of two years. Assessments include laboratory tests for liver, kidney, blood counts, coagulation, oxygen levels, and heart function. Female participants of childbearing potential must undergo pregnancy testing and use contraception. The main outcome measured is the incidence of treatment-emergent and serious adverse events. Participant safety and treatment effects will be carefully evaluated throughout the trial period which starts in September 2024 and may continue until the end of 2027.

Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases