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A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases

StatusRecruiting
PhasePhase 1
Started2025-08-13
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 2, 2026 (before its estimated August 13, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-02-27
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2025-08-18
Study Status, Eligibility v1
Eligibility criteria+80 characters
[...] ), regardless of gender. Essential Organ Function Criteria: 2.1 Bone marrow: Neutrophils ≥1×10^9/L (within 2 weeks, excludin [...] ulocyte colony-stimulating factor use); Hemoglobin ≥60 g/L. 2.2 Liver: ALT/AST ≤3×ULN (disease-related elevations permitted). TBIL≤1.5×ULN (disease-related elevations permitted). 2.3 Renal: CrCl≥30mL/min (Cockcroft-Gault formula, excluding acute declines). 2.4 Coagulation: INR/PT ≤1.5×ULN. 2.5 Cardiovascular: Hemodynamic stability. 3. Fertile females or males with partners of childbearing age m [...] 7 days pre-enrollment) for fertile females; non-lactating. 4. Voluntary partic [...] [...]
2025-08-08
Original filing
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 3E6 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 Institute of Hematology \& Blood Diseases Hospital.
Trial Details
NCT Number NCT07123519
Lead Sponsor China Immunotech (Beijing) Biotechnology Co., Ltd.
Collaborators: Institute of Hematology & Blood Diseases Hospital, China
Conditions Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN), Sjogren's Syndrome (SS), Inflammatory Myopathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Antiphospholipid Syndrome (APS)
Enrollment 18 participants
Start Date 2025-08-13
Primary Completion 2026-08-13 (estimated)
Study Completion 2027-08-13 (estimated)
Updated on ClinicalTrials.gov 2026-03-02