New antibody A-319 takes aim at Hard-to-Treat lupus

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18-60 years old, regardless of gender; 2. Participants diagnosed with SLE according to the American College of Rheumatology (ACR) 1997 revised criteria for SLE at least 24 weeks prior to signing the informed consent form; 3. Active/refractory systemic lupus erythematosus; 4. Positive test results for at least one of the following autoantibodies at screening: antinuclear antibodies (ANA) immunofluorescence assay at a titer of ≥1:80; anti-dsDNA; or anti-Smith (anti-Sm); 5. Receive the standardized and stable treatment for at least 30 days before the first administration of the study drug; 6. Female participants tested negative for pregnancy, and participants agreed to use effective contraception throughout the trial; 7. Have the ability to understand the nature of the research and voluntarily sign an informed consent form; 8. Participants can communicate well with the researchers and complete all visits according to the requirements of the plan. 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.