Study of YTS109 Cell Treatment for Adults Aged 18-65 with Relapsed or Refractory Autoimmune Diseases Including Lupus and Sjogrens Syndrome

What this Trial Is About

Researchers are evaluating the safety and effects of YTS109 cells in adults aged 18 to 65 with relapsed or refractory autoimmune diseases, including Systemic Lupus Erythematosus SLE, Lupus Nephritis LN, Sjogrens Syndrome, Inflammatory Myopathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, and Antiphospholipid Syndrome. This phase 1, single-arm, open-label trial aims primarily to assess safety while also studying how well YTS109 cells work and their behavior in the body. About 18 patients will participate in this study conducted at Bengbu Third Peoples Hospital. Participants will receive a single infusion of YTS109 cells, starting at a dose of 3x106 STAR-T cells per kilogram, with dose escalation guided by a 33 principle. There are no placebo or comparator groups. The infusion is given once, and patients will be monitored closely for safety and treatment effects over several weeks. The study includes detailed follow-up periods to observe adverse events and treatment efficacy. During the study, participants will undergo evaluations at 2, 4, 8, 12, 24, and up to 52 weeks after treatment. These include assessments of adverse events, measurements of YTS109 cell levels in the blood at multiple time points, cytokine levels, and reconstitution of B cells in peripheral blood. Patients will provide informed consent and comply with study procedures, including use of contraception if applicable. The study also tracks various clinical and laboratory parameters to monitor safety and treatment response over time.

An Exploratory Clinical Study of YTS109 Cell for R/R Autoimmune Diseases