Clinical Trial

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

Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated May 13, 2025 (before its estimated April 25, 2026 completion). Its status may not reflect the trial's current state.
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 (1×10⁶-2×10⁶ 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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-17.
Status change: Not Yet Recruiting → Recruiting 2025-05-08
Trial Details
NCT Number NCT06943937
Lead Sponsor China Immunotech (Beijing) Biotechnology Co., Ltd.
Conditions Lupus Nephritis (LN), Immune Thrombocytopenia (ITP)
Enrollment 36 participants
Start Date 2025-04-16
Primary Completion 2026-04-25 (estimated)
Study Completion 2027-04-25 (estimated)
Updated on ClinicalTrials.gov 2025-05-13