A Study of SCTB35 in Patients with Systemic Lupus Erythematosus

Exclusion Criteria33

• Severe active or unstable lupus-related neuropsychiatric disorders;
• Other autoimmune diseases that may interfere with efficacy evaluation;
• Catastrophic antiphospholipid syndrome;
• Received treatments that may affect the drug's effect:
• Received live vaccines or attenuated vaccines within 28 days prior to baseline or screening;
• Clinically significant bleeding risk;
• Abnormal laboratory results:
• AST or ALT >2.5 x ULN;
• Total bilirubin >1.5 x ULN;
• ANC <1.5x10⁹/L;
• Platelets <75x10⁹/L;
• Hemoglobin <100g/L;
• eGFR <30 mL/min/1.73 m²;
• Positive serum HCG;
• Received any investigational treatment within 30 days prior to baseline or within 5 half-lives of the investigational drug (whichever is longer);
• Participants with recurrent, chronic, or other active infections as assessed by the investigator;
• Severe or uncontrolled disease, which would prevent participation in the study;
• Positive viral serology tests, including HIV, HCV, and HBV;
• Tuberculosis screening: Known active tuberculosis or latent tuberculosis infection (LTBI);
• Any type of active infection except nail bed fungal infections;
• Severe infections;
• History of progressive multifocal leukoencephalopathy (PML);
• Diagnosed with type 1 or type 2 diabetes with poor control;
• Uncontrolled hypertension (systolic >140 mmHg or diastolic >90 mmHg);
• History of malignancy within 5 years prior to baseline;
• Alcohol abuse or drug misuse within 12 months prior to screening;
• Intolerance to the study drug or contraindications, including a history of severe allergic reactions to monoclonal antibodies or any component of SCTB35 injection;
• Required hospitalization for major surgery within 4 weeks prior to screening or within 12 weeks post-study drug administration;
• Participants with mental disorders or poor compliance;
• Severe lupus nephritis;
• History of solid organ or hematopoietic stem cell/bone marrow transplant, or expected to undergo transplant surgery during the study;
• Pregnant or breastfeeding;
• Any other condition that the investigator deems unsuitable for participation in the study.