An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease
Trial Parameters
Brief Summary
An exploratory clinical study of the safety and efficacy of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease
Eligibility Criteria
Inclusion Criteria: 1. Age ranges from 18 to 65 years old (including threshold), regardless of gender. 2. Positive expression of CD19 on peripheral blood B cells determined by flow cytometry. 3. The functions of important organs meet the following requirements: 1. Bone marrow hematopoietic function needs to meet: Neutrophil count ≥1×109/L; Hemoglobin ≥60g/L; 2. Liver function: ALT≤3×ULN; AST≤3×ULN; TBIL≤1.5×ULN; 3. Renal function: creatinine clearance (CrCl) ≥30 ml/minute; 4. Coagulation function: International standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) ≤1.5×ULN; 5. Heart function: good hemodynamic stability; 4. Female subjects with fertility and male subjects whose partners are women of childbearing age are required to use medically approved contraception or abstinence during the study treatment period and at least 6 months after the end ofthe study treatment period; Female subjects of childbearing age tested negative for serum HCG within 7 days before enrollment in the