A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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.
Eligibility Criteria
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. Detection of positive CD19 expression on peripheral blood B cells by flow cytometry. 3. 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. 4. Fertile females or males with partners of childbearing age must use medically approved contraception or abstain during and ≥12 months post- treatment. Negative se