An Exploratory Clinical Study of SCAR02 Targeting BCMA and CD19 for the Treatment of Refractory Autoimmune Diseases
Trial Parameters
Brief Summary
This is an open label, single-site, dose-escalation study in up to 18 participants with refractory autoimmune diseases. This study aims to evaluate the safety and efficacy of the treatment with Anti-BCMA and CD19 CART
Eligibility Criteria
Inclusion Criteria: 1. Sign the informed consent form. 2. At the time of signing the informed consent form, the age of 18 years old or above, both male and female. 3. Bone marrow hematopoietic function is satisfied: white blood cell count ≥3×10\^9/L; neutrophil count ≥1×10\^9/L (not receiving colony-stimulating factor within 2 weeks prior to screening); hemoglobin ≥60g/L. 4. Liver function fulfillment: ALT≤3×ULN; AST≤3×ULN; TBIL≤3×ULN. 5. Renal function fulfillment: creatinine clearance CrCl ≥ 60mL/min. 6. Coagulation function meets: international standard ratio INR \<1.5 times ULN, prothrombin time PT \<1.5 times ULN. Patients with rheumatoid arthritis must also meet the following enrollment criteria: 1. Diagnosis of rheumatoid arthritis according to the 2010 ACR / EULAR diagnostic criteria. 2. Fulfillment of one of the following conditions: DAS28-ESR \>3.2 or CDAI \>10 at 3 months after use of a standard treatment regimen prior to screening; inability to taper hormones (prednisone) t