Study of YTS109 Cell Therapy for Adults Aged 18-65 With Relapsed or Refractory Autoimmune Diseases Including Lupus, Sjogrens Syndrome, and Others

What this Trial Is About

Researchers are evaluating the safety and effectiveness of YTS109 cell therapy in adults aged 18 to 65 with relapsed or refractory autoimmune diseases such as Systemic Lupus Erythematosus SLE, including lupus nephritis and immune thrombocytopenia, Sjogrens Syndrome, systemic sclerosis, inflammatory myopathy, ANCA-associated vasculitis, and antiphospholipid syndrome. This phase 1, open-label trial aims primarily to assess the safety of YTS109 cells, while also studying their impact on disease symptoms and how the cells behave in the body. Participants will receive a single infusion of YTS109 cells, starting at a dose of 3 x 106 STAR-T cells per kilogram. The dose will be adjusted following a 33 escalation design to determine the best dose. This single-arm study will include approximately 18 patients who will be observed over time to monitor outcomes and any side effects. During the trial, participants will undergo assessments for safety and efficacy at 2, 4, 8, and 12 weeks after infusion, with follow-up for adverse events extending to 24 weeks and continued observation up to 52 weeks. Researchers will also measure levels of YTS109 cells and related biomarkers in the blood at multiple time points to understand how the cells are processed in the body. Participants will have laboratory tests and clinical evaluations throughout the study and follow-up period to monitor their condition and treatment effects.

Exploratory Clinical Study on YTS109 Cell Therapy for Autoimmune Diseases