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
| Condition(s) | Systemic Lupus Erythematosus (SLE), Systemic Sclerosis, Sjogren's Syndrome (SS), Inflammatory Myopathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Antiphospholipid Syndrome |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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 e |
| Who can participate | Inclusion Criteria: \- Subjects must meet both the following common inclusion criteria and disease-specific inclusion criteria simultaneously to be eligible for participation in this study: Common inclusion criteria: 1. Age ranges from 18 to 65 years old (including threshold), regardless of gender. 2. Essential Organ Function Criteria: <!-- --> 1. Bone marrow: Neutrophils ≥1×10\^9/L (within 2 weeks, excluding granulocyte colony-stimulating factor use); Hemoglobin ≥60 g/L. 2. Liver: ALT/AST ≤3×ULN (disease-related elevations permitted). TBIL≤1.5×ULN (disease-related elevations permitted). 3. Renal: CrCl≥30mL/min (Cockcroft-Gault formula, excluding acute declines). 4. Coagulation: INR/PT ≤1.5×ULN. 5. Cardiovascular: Hemodynamic stability. 3. Fertile females or males with partners of childbea |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | China Immunotech (Beijing) Biotechnology Co., Ltd. |
| Locations | Xuzhou, Jiangsu, China; Xuzhou, Jiangsu, China |
| Start date | 2025-11-13 |
| NCT ID | NCT07236801 |
| Official listing | https://clinicaltrials.gov/study/NCT07236801 |