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Phase 1Terminated

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

An Exploratory Clinical Study of YTS109 Cell in Subjects With Refractory Disease Systemic Lupus Erythematosus

Sponsor
China Immunotech (Beijing) Biotechnology Co., Ltd. (Industry)
Enrolment
2 enrolled
Conditions
Lupus Nephritis (LN); Immune Thrombocytopenia (ITP)
Interventions
YTS109 cell injection
Ages
adults, older adults
Registry
NCT06943937

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Incidence of Treatment-Emergent Adverse Events

History

  1. Last registry update

  2. Primary completion

  3. Registered

  4. Started