Study to Evaluate Safety and Effectiveness of Autologous CD19 CAR-T Therapy for Adults with Relapsed or Refractory Autoimmune Diseases

What this Trial Is About

Researchers are evaluating the safety and preliminary efficacy of autologous CD19 CAR-T therapy in adults aged 18 to 65 with relapsed or refractory autoimmune diseases, including systemic lupus erythematosus SLE, systemic sclerosis SSc, antineutrophil cytoplasmic antibody-associated vasculitis AAV, idiopathic inflammatory myopathy IIM, and Sjogrens syndrome SS. This exploratory clinical trial uses a 33 dose escalation design to find the maximum tolerated dose and recommended dose. The study will monitor dose limiting toxicity DLT and follow participants for 24 months after treatment. Participants receive a single intravenous infusion of CD19 CAR-T cells at one of three dose levels, starting at 0.5 million CAR T cells per kilogram. If no severe toxicity occurs in three subjects at a dose level, the dose increases for the next group. If toxicity occurs, additional subjects are added or dosing is adjusted per protocol. The Safety Review Committee oversees dose escalation decisions based on safety, efficacy, and pharmacokinetic data. During the study, participants are closely monitored for side effects and treatment response, particularly for DLT within 28 days post-infusion. Follow-up includes safety and efficacy assessments over two years. Eligibility requires stable organ function and meeting disease-specific criteria. The study excludes individuals with active infections, certain cancers, recent use of specific medications, or significant cardiovascular disease. Participants must agree to effective contraception and provide informed consent.

Autologous CD19CAR-T Therapy for Recurrent/Refractory Autoimmune Diseases