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.
Age ranges from 18 to 65 years old (including threshold), regardless of gender.
Detection of positive CD19 expression on peripheral blood B cells by flow cytometry.
Bone marrow: Neutrophils ≥1×10^9/L (within 2 weeks, excluding granulocyte colony-stimulating factor use).
Liver: ALT/AST ≤3×ULN (disease-related elevations permitted). TBIL ≤1.5×ULN (disease-related elevations permitted).
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 YTS109 cell (1.5 E6 STAR +T cells/kg) once in this study.
Incidence of Treatment-Emergent Adverse Events
1. Efficacy Endpoint； 2. Types, severity, and frequency of adverse events (AEs).
Efficacy Evaluation in relapsed/refractory autoimmune diseases
The proportion of subjects achieving complete response (CR), partial response (PR), or other responses.
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 Medical Center of Chinese PLA General Hospital
Collaborator
