Exploring YTS109 Cell Therapy for Adults with Refractory Lupus Nephritis and Immune Thrombocytopenia

What this Trial Is About

Researchers are evaluating the safety and potential benefits of YTS109 cells in adults with refractory Lupus Nephritis LN and Systemic Lupus Erythematosus-Immune Thrombocytopenia SLE-ITP. These are serious and difficult-to-treat conditions associated with systemic lupus erythematosus SLE, which affects multiple organs and involves persistent immune system problems. This exploratory study aims to gather early data on safety, effectiveness, and how the therapy behaves in the body in patients who have not responded to standard treatments. Participants will receive a single infusion of YTS109 cells, a universal allogeneic STAR-T cell therapy targeting CD19 to reduce B cells involved in autoimmune responses. The dose ranges from 1 million to 2 million STAR-T cells per kilogram of body weight. This is a single-arm, open-label trial conducted at one center, where all subjects receive the investigational treatment. The study will monitor patients for 52 weeks after treatment to assess safety and response. During the study, participants will be closely monitored for adverse events and dose-limiting toxicities over the first 28 days, with continued observation for up to a year. Researchers will evaluate kidney response in LN patients and platelet response in SLE-ITP patients at 12 weeks post-treatment. Blood samples will be collected to analyze pharmacokinetics and pharmacodynamics of the YTS109 cells. Participants will provide informed consent and undergo regular assessments throughout the study period.

A Clinical Study of YTS109 Cell in R/R Systemic Lupus Erythematosus