A Clinical Study of YTS109 Cell in R/R Systemic Lupus Erythematosus
Status:
RECRUITING
Trial end date:
2027-04-25
Target enrollment:
Participant gender:
Summary
This study evaluates the safety and efficacy of YTS109 cells in adults with refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus-Immune Thrombocytopenia (SLE-ITP). Approximately 36 patients aged 18-65 will receive a single infusion of YTS109 cells (110-210 cells/kg). The primary endpoint is observations of types, severity, and frequency of dose-limiting toxicities (DLTs) and adverse events (AEs). Secondary endpoints include the complete renal response (CRR) rate at week 12 in LN, and proportion of subjects achieving complete response (CR) or partial response (PR) at week 12 post-treatment in SLE-ITP. This single-arm, open-label trial will enroll patients across Beijing GoBroad Hospital in China.
Phase:
PHASE1
Details
Lead Sponsor:
China Immunotech (Beijing) Biotechnology Co., Ltd.