Universal CAR-T Cells (BRL-301) in Refractory Systemic Lupus Erythematosus
Trial Parameters
Brief Summary
This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the refractory systemic lupus erythematosus.
Eligibility Criteria
Inclusion Criteria: 1. Age range from 18 to 65 years old (including threshold), regardless of gender; 2. Subjects diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria; ANA ≥ 1:80, or positive for anti dsDNA and/or anti Sm antibodies; 3. The condition becomes active again after conventional treatment is ineffective or the disease relapses. Conventional treatment is defined as the use of two or more drugs, including corticosteroids (more than 1mg/kg/d) and any one or more of the following immunomodulatory drugs for over six months: antimalarial drugs, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biologics including rituximab, belimumab, etanercept, etc. 4. At least one BILAG2004 Class A or two Class B score, or both; 5. SELENA-SLEDAI score ≥ 8 points; 6. The positive expression and expression rate of CD19 on peripheral blood B cells determined by flow cytometry; 7. The functions of importa