A Clinical Study of MIL62 in Systemic Lupus Erythematosus

Inclusion Criteria:

1. Age 18-80 ;
2. Diagnosis of systemic lupus erythematosus according to European League AgainstRheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria ;
3. Positive antinuclear antibodies (ANA) ≥ 1:80 at screening or positive anti- dsDNA ;
4. Low C3 and/or low C4 complement at screening ;
5. High disease activity at screening ;
6. On a stable SLE treatment regimen for at least 30 days prior to the firstadministration；
7. Able and willing to provide written informed consent and to comply with the studyprotocol.

Exclusion Criteria:

1. Unsufficient organ function;
2. Have received treatment with B cell targeted therapy within 9 months prior to thefirst administration;
3. Subjects with CD4+ T lymphocyte count < 200 cells/μL;
4. Receipt of any of the following prior to the first administration:Cyclophosphamide,Calcineurin inhibitor, blood transfusion ;
5. Received TNF inhibitor, Beliumumab, and Tetasercept within 3 months prior to the firstadministration; Interleukin monoclonal antibody, JAK inhibitor, BTK inhibitor within 2months prior to the first administration;
6. Received live or attenuated vaccination within 28 days prior to the firstadministration;
7. Participated in other clinical trials within 28 days prior to the firstadministration;
8. Concomitant with other serious diseases；
9. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C;
10. Subjects with known history of severe allergic reactions to humanized monoclonalantibodies，MIL62；
11. Breastfeeding or pregnant women;
12. Childbearing potential and unwillingness or impossibility to comply with ascientifically acceptable birth-control method;
13. Other conditions unsuitable for participation in this study determined by theInvestigator.