Exploratory Clinical Study on YTS109 Cell Therapy for Autoimmune Diseases

This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and SLE-ITP, Sjogren's Syndrome, etc. Aproximately 18 patients aged 18-65 will receive a single infusion of YTS109 cells. The dose groups are set to commence at 3×10⁶ STAR -T cells/kg, employing a 3+3 escalation principle for dose titration. The primary objective of this study is to evaluate the safety of YTS109 cells therapy in treating recurrent/refractory autoimmune diseases, while the secondary objectives are to assess the efficacy of YTS109 cells as well as their pharmacokinetic and pharmacodynamic characteristics. 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 The First Affiliated Hospital of Anhui Medical University.

NCT Number	NCT07236801
Lead Sponsor	China Immunotech (Beijing) Biotechnology Co., Ltd. Collaborators: The Affiliated Hospital of Xuzhou Medical University
Conditions	Systemic Lupus Erythematosus (SLE), Systemic Sclerosis, Sjogren's Syndrome (SS), Inflammatory Myopathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Antiphospholipid Syndrome
Enrollment	18 participants
Start Date	2025-11-13
Primary Completion	2026-11-13 (estimated)
Study Completion	2027-11-13 (estimated)
Updated on ClinicalTrials.gov	2026-03-02