Clinical Study of AFN50 Injection in the Autoimmune Diseases

Inclusion Criteria

• •1. Be able to understand and voluntarily sign the written informed consent form;
• •2. Patients aged between 18 and 69 (inclusive), of any gender, diagnosed with SLE according to the 2019 EULAR/ACR SLE diagnostic criteria;
• •3. A history of SLE for at least 6 months, having used a stable standard treatment regimen for at least 8 weeks, with the dosage stable for 2 weeks, yet the disease remains active or has relapsed; Standard treatment refers to the stable use of the following drugs alone or in combination: non-steroidal anti-inflammatory drugs (NSAIDs), antimalarials, corticosteroids; immunosuppressants (including but not limited to cyclophosphamide, methotrexate, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine); targeted drugs (including but not limited to belimumab, telitacicept, eculizumab, rituximab);
• •4. Oral corticosteroids are prednisone (or equivalent drug) ≥7.5mg/day and ≤30mg/day. If used in combination with immunosuppressants, there is no minimum daily dose requirement;
• •5. Standardized treatment failure with hydroxychloroquine or at least two immunosuppressants;
• •6. Screening period tests meet: positive blood antinuclear antibody (ANA), and/or positive anti-double-stranded DNA (anti-dsDNA) antibodies, and/or hypocomplementemia (low C3 and/or C4);
• •7. Screening period SLEDAI-2K score ≥6 points. If scoring includes low complement and/or anti-ds-DNA antibodies, the score for SLEDAI-2K clinical symptoms (excluding low complement and/or anti-ds-DNA antibodies) should be ≥4 points;
• •8. Appropriate bone marrow, coagulation, cardiopulmonary, liver, and kidney functions.
• •Bone marrow function: Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L (no granulocyte colony-stimulating factor (G-CSF) administered within 7 days prior to screening; a 14-day interval required for long-acting G-CSF); Hemoglobin (Hb) ≥80 g/L (no red blood cell transfusion within 14 days prior to screening; recombinant human erythropoietin is permitted. For patients meeting the Hb ≥80 g/L inclusion criterion, red blood cell transfusion is allowed during treatment to maintain hemoglobin level at ≥80 g/L); Platelet Count (PLT) ≥50×10⁹/L, Absolute Lymphocyte Count (ALC) ≥0.8×10⁹/L.
• •Coagulation function: International Normalized Ratio (INR) or Activated Partial Thromboplastin Time (APTT) ≤1.5 times the upper limit of normal (ULN).
• •Cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥40% as measured by echocardiography (ECHO).
• •Pulmonary function: Dyspnea of ≤CTCAE Grade 1; pulse oxygen saturation (SpO2) \>92% under room air.
• •Hepatic function: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤2.5×ULN; total bilirubin ≤1.5×ULN.
• •Renal function: Creatinine clearance rate (calculated by the Cockcroft-Gault formula) ≥50 mL/min, without the need for fluid support;
• •9. Baseline oxygen saturation \>92% without oxygen supplementation;
• •10. Non-pregnant/non-lactating participants. Women of childbearing potential must have a negative serum or urine pregnancy test result (women who have undergone surgical sterilization or postmenopausal women for at least 2 years are not considered women of childbearing potential) and be willing to adopt contraceptive measures within 12 months after drug infusion.