IASO207 Injection for Active Refractory Systemic Lupus Erythematosus (SLE)

Inclusion criteria

• . Subjects aged 18-75 years old, regardless of gender.
• . Subjects diagnosed with active refractory SLE: a) Confirmed by the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus Erythematosus Collaborative Clinic (SLICC) criteria for at least 24 weeks; b) SLE Disease Activity Index 2000 (SLEDAI-2K) score ≥ 8, with at least 1 organ system having a BILAG-2004 A-class activity score at screening, or 2 organ systems having a BILAG-2004 B-class activity score; c) Previously treated with standardized glucocorticoids and at least two immunosuppressants/adjusters, antimalarial drugs or biologics for at least 3 months.
• . Positive for disease-related pathogenic antibodies: Anti-nuclear antibody (ANA) positive and/or anti-dsDNA positive and/or anti-Smith positive.
• . Allowed to use ≤ 20mg/d prednisone or equivalent dose of corticosteroids at screening, and use at a stable dose for at least 2 weeks. Note: Local or inhaled corticosteroids (or its immunomodulators) can be used concurrently;
• . If antimalarial treatment has been initiated for ≥ 12 weeks before screening and is used at a stable dose for at least 8 weeks, it is allowed to continue in the study (maximum hydroxychloroquine dose ≤ 400mg/d).
• . If immunosuppressants have been used before screening, they must be used at a stable dose for at least 4 weeks.
• . Laboratory tests must meet the following conditions: a) Blood routine: Absolute neutrophil count (ANC) ≥ 1.0×10\^9/L; Absolute lymphocyte count (ALC) ≥ 0.3×10\^9/L; Hemoglobin ≥ 60 g/L; Platelets ≥ 50×10\^9/L b) Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5× upper limit of normal (ULN); Serum total bilirubin ≤ 1.5×ULN (Gilbert's syndrome ≤ 3.0×ULN).