Clinical Study of A-319 in the Treatment of Active/Refractory Systemic Lupus Erythematosus

Exclusion Criteria

• •1. Severe kidney disease;
• •2. Participants who have central nervous system diseases caused by SLE or non-SLE disease within 8 weeks before the first administration of the study drug;
• •3. Abnormities of main organ function at screening;
• •4. Medical history that the researchers believe will pose risk to the safety of the participants, or will affect the safety or effectiveness analysis of the study drug;
• •5. Active mycobacterium tuberculosis infection;
• •6. Active hepatitis, or hepatitis B virus surface antigen positive, or hepatitis B virus core antibody positive and hepatitis B virus deoxyribonucleic acid positive, ,or hepatitis C virus (HCV) antibody positive with detectable HCV ribonucleic acid (RNA).;
• •7. History of human immunodeficiency virus infection, or positive antibodies at screening;
• •8. Positive syphilis spirochete antibody at screening (except false positive caused by SLE);
• •9. Participants with chronic active infection or acute infection need systemic anti-infection treatment within 2 weeks before screening, or have superficial skin infection requiring treatment within 1 week before screening;
• •10. Have undergone major surgery or unhealed wounds, ulcers or fractures within 4 weeks before the first administration of the study drug, or plan to perform major surgery during the study period;
• •11. Participants diagonosed with malignant tumors within 5 years before screening;
• •12. History of important organ transplantation or hematopoietic stem cells/or bone marrow transplantation;
• •13. Have been vaccinated or plan to receive live vaccine or live attenuated vaccine during the research period within 4 weeks before the first administration of the study drug;
• •14. Participated in any clinical trial within 4 weeks before the first administration of the study drug or within 5 half-lives of the study drug of the clinical trial;
• •15. Received targeted drugs (rituximab, JAK inhibitors, etc.) at a specific time period before the first administration of the study drug;
• •16. Received intravenous immunoglobulin, prednisone ≥100mg/d or equivalent glucocorticoid therapy within 4 weeks before the first administration of the study drug, or plasma replacement;
• •17. Received IL-2, thalidomide, rethidone and traditional Chinese medicine within 4 weeks before the first administration of the study drug;
• •18. Known allergies to monoclonal antibody drugs, or allergies to A-319 excipients;
• •19. Participants with depression or suicidal thoughts;
• •20. Women who are pregnant or breastfeeding, or women who plan to be pregnant or breastfeeding during the study period; or men whose sexual partners plan to become pregnant during the study period;
• •21. Any reason that the researchers believe will hinder the subject's participation in the study.