A Clinical Study of Anti-CD19 CAR-NK Cells in the Treatment of Refractory/Relapsed Systemic Lupus Erythematosus
This study is a single-center, open-label, single-arm trial. The aim of this study is to investigate the safety and efficacy of anti-CD19 CAR-NK cells in patients with refractory/relapsed systemic lupus erythematosus.
• Voluntarily participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up;
• Age range from 18 to 65 years old, regardless of gender;
• Fulfilling the 2019 ACR/EULAR classification criteria of SLE;
• Presence of anti-dsDNA or decreased C3/C4 levels;
• SLEDAI-2K≥8;
• Routine treatment is ineffective or the disease relapses after remission. Definition of routine treatment: use more than two drugs, including glucocorticoid (more than 1mg/kg/d), and any two or more of the following immunomodulatory drugs for more than 6 months: cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, leflunomide, tacrolimus, ciclosporin, iguratimod, biological agents, including rituximab, belizumab, or telitacicept;
• Hemoglobin ≥ 80g/L; white blood cell count ≥ 3 × 10\^9/L;neutrophil count ≥ 1.5 × 10\^9/L; platelets ≥ 30 × 10\^9/L;
• The functions of important organs are basically normal: ALT ≤ 2 × ULN; AST ≤ 2 × ULN; eGFR ≥ 30ml/min/1.73m2; total bilirubin ≤2.0 mg/dL; cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%; non-oxygenated blood oxygen saturation \>94%; prothrombin time (PT) ≤ 1.5 × ULN;international standardized ratio (INR) ≤ 1.5 × ULN;
• Females of childbearing potential must use effective contraception during the study.