The objective of this study is to evaluate the efficacy and safety of BCMA/CD19 chimeric antigen receptor (CAR)-modified T cells in the treatment of autoimmune diseases.
Age, 18-65 years old (inclusive), weight >=45kg, male and female;
Additional enrollment criteria for systemic lupus erythematosus A. The SLEDAI score of the patient before enrollment >= 7 points B. Failure to receive the following treatments: oral prednisone >=20 mg/d; Cyclophosphamide 0.4 to 0.6 g/m2 once every two weeks for 6 months, or other immunosuppressants such as mycophenolate mofetil 2 g/day for 3 months without remission.
Additional enrollment criteria for antiphospholipid syndrome A. Cardiolipin antibody, lupus anticoagulant factor, and anti-β2-glycoprotein 1 antibody were all positive before enrollment.
Sjögren's disease additional enrollment criteria A. Positive anti-Ro/SSA antibody screen. B. ESSDAI>= 6 POINTS
Use of rituximab or other monoclonal antibodies within 1.6 months.
Received high-dose glucocorticoids (>1 mg/kg/d) within 1 month.
Serious complications: including heart failure (>= NYHA Class III), renal insufficiency (creatinine clearance <=30 ml/min), hepatic insufficiency (serum ALT or AST greater than three times the upper limit of normal, or total bilirubin greater than the upper limit of normal)
Other severe, progressive, or uncontrollable hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral diseases (including demyelinating diseases such as multiple sclerosis).