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.
Bone marrow: Neutrophils ≥1×10^9/L (within 2 weeks, excluding granulocyte colony-stimulating factor use); Hemoglobin ≥60 g/L.
Liver: ALT/AST ≤3×ULN (disease-related elevations permitted). TBIL≤1.5×ULN (disease-related elevations permitted).
Renal: CrCl≥30mL/min (Cockcroft-Gault formula, excluding acute declines).
Coagulation: INR/PT ≤1.5×ULN.
Individuals with a severe history of drug allergies or those with an allergic constitution;
Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;
Subjects with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system vasculitis resulting from the underlying disease);
Subjects whose cardiac function cannot tolerate the study interventions;
Single group
YTS109 cell
DrugSubjects 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.
Incidence of Treatment-Emergent Adverse Events
1. Types, severity, and frequency of adverse events (AEs); 2. Incidence of dose-limiting toxicity (DLT).
Efficacy Evaluation in relapsed/refractory autoimmune diseases
The proportion of subjects achieving complete response (CR), partial response (PR), or other responses at week 12.
Maximum Plasma Concentration of YTS109 (Cmax)
To evaluate the metabolic characteristics of YTS109
Area Under the Plasma Concentration-Time Curve (AUC) of YTS109
To evaluate the metabolic characteristics of YTS109
Time to Reach Maximum Plasma Concentration (Tmax) of YTS109
To evaluate the metabolic characteristics of YTS109
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China Immunotech (Beijing) Biotechnology Co., Ltd.
Lead sponsor
The First Affiliated Hospital of Anhui Medical University
Collaborator
