An exploratory clinical study of the safety and efficacy of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease
Age ranges from 18 to 65 years old (including threshold), regardless of gender.
Positive expression of CD19 on peripheral blood B cells determined by flow cytometry.
Bone marrow hematopoietic function needs to meet: Neutrophil count ≥1×109/L; Hemoglobin ≥60g/L;
Liver function: ALT≤3×ULN; AST≤3×ULN; TBIL≤1.5×ULN;
People with severe drug allergy or allergic constitution;
the presence or suspicion of fungal, bacterial, viral or other infections that cannot be controlled or require treatment;
Subjects with central nervous system disorders (excluding pre-existing epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis as a result of the disease);
Patients with cardiac dysfunction;
China Immunotech (Beijing) Biotechnology Co., Ltd.
Lead sponsor
Shanghai Changzheng Hospital
Collaborator