Exploring Safety and Effectiveness of YTS109 Cell Injection for Adults 18-65 with Recurrent or Hard-to-Treat Autoimmune Diseases

What this Trial Is About

Researchers are evaluating the safety, initial effectiveness, and pharmacokinetic and pharmacodynamic characteristics of YTS109 cell injections in people with recurrent or difficult-to-treat autoimmune diseases. This exploratory clinical trial focuses on patients who have conditions such as systemic lupus erythematosus, Sjogrens syndrome, systemic sclerosis, inflammatory myopathy, ANCA-associated vasculitis, and antiphospholipid syndrome. The study aims to better understand how YTS109 cells behave and impact these diseases when conventional treatments have not worked. Participants will receive a single injection of YTS109 cells at a dose of 3 million STAR T cells per kilogram of body weight. The treatment is administered once during the study. The trial does not include a placebo or comparison group and is conducted without masking or blinding. The study covers a treatment assessment period of 3 months, with additional evaluations extending up to 6 months for some measures. During the study, participants will undergo safety monitoring for treatment-emergent adverse events over 3 months. Researchers will measure efficacy outcomes for each autoimmune condition at 3 and 6 months. Blood tests will assess YTS109 cell levels and pharmacodynamics at 3 and 6 months as well. Participants will be closely followed for organ function, immune responses, and disease activity, with a total involvement period spanning up to 6 months after treatment.

An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease