Clinical Trial

A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases

Recruiting Phase 1
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Record status
This record was last updated July 14, 2025 (before its estimated May 19, 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 relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), etc. Aproximately 6-12 patients aged 18-65 will receive a single infusion of YTS109 cells (1.5×10⁶ cells/kg). The main purpose of exploratory clinical research is to explore the efficacy and safety of YTS109 cell and the lymphodepletion regimen. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across Chinese People's Liberation Army (PLA) General Hospital.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-16.
Status change: Not Yet Recruiting → Recruiting 2025-07-10
Trial Details
NCT Number NCT06978647
Lead Sponsor China Immunotech (Beijing) Biotechnology Co., Ltd.
Collaborators: The First Medical Center of Chinese PLA General Hospital
Conditions Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), Inflammatory Myopathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Antiphospholipid Syndrome (APS), Rheumatoid Arthritis (RA), IgG4-Related Diseases, Sjogren's Syndrome
Enrollment 12 participants
Start Date 2025-05-19
Primary Completion 2026-05-19 (estimated)
Study Completion 2027-05-19 (estimated)
Updated on ClinicalTrials.gov 2025-07-14