Phase 1 Study of YTS109 Cell Therapy for Adults with Relapsed or Refractory Autoimmune Diseases

What this Trial Is About

Researchers are evaluating the safety and effectiveness of YTS109 cells in adults aged 18 to 65 who have relapsed or refractory autoimmune diseases such as Systemic Lupus Erythematosus SLE, Lupus Nephritis LN, SLE-associated immune thrombocytopenia SLE-ITP, Sjogrens Syndrome, Inflammatory Myopathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, and Antiphospholipid Syndrome APS. This Phase 1, open-label trial will enroll about 18 patients to study safety, effectiveness, and how the YTS109 cells behave in the body. Participants will receive a single infusion of YTS109 cells starting at a dose of 3 million STAR-T cells per kilogram of body weight. The dose will be increased gradually using a 33 escalation method. The study focuses on observing adverse events and evaluating treatment response over several weeks. The trial is conducted by China Immunotech Beijing Biotechnology Co., Ltd. at the Institute of Hematology & Blood Diseases Hospital. During the study, patients will be monitored closely with assessments at 2, 4, 8, 12, 24, and up to 52 weeks after treatment. Researchers will track the types, severity, and frequency of any adverse events, measure drug levels in the blood, evaluate immune system responses, and assess disease activity. This detailed monitoring includes laboratory tests and clinical evaluations to ensure patient safety and to understand how the therapy affects the autoimmune conditions over time.

A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases