Phase Ib Study of SC Milatuzumab in SLE

Inclusion Criteria: * Male or female ≥ 18 years old * Signed written informed consent before study entry * Diagnosis of SLE by American College of Rheumatology revised criteria (meets ≥ 4 criteria) * Positive ANA (titer ≥ 1:80) at study entry * At least 1 BILAG A or 2 BILAG B scores in any organ/body system and ≥ 6 SELENA-SLEDAI score * Receiving at least 5.0 mg/day oral prednisone (or equivalent) at stable doses for at least 4 weeks prior to study entry * If receiving immunosuppressives or antimalarial agents, at stable doses for at least 4 weeks prior to study entry Exclusion Criteria: * Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test. * Women of childbearing potential and fertile men not practicing or unwilling to practice birth control during the study * Rituximab, belimumab, other prior antibody, investigational or experimental therapy within 6 months * Allergic to murine, chimeric, humanized or human antibodies * Hematologic abnormalities not attributed to lupus: hemoglobin \< 8.0 mg/dL, WBC \< 2000/L, ANC \< 1500/L, platelets \< 50,000/L, * AST, ALT or alkaline phosphatase \> 3 times upper limit of normal and not attributed to lupus * Serum creatinine \> 2.5 mg/dL, proteinuria \> 3.5 g/day * Received live vaccine within 4 weeks * Thrombosis, spontaneous or induced abortion, stillbirth or live birth within 4 weeks * Antiphospholipid antibodies AND a history of thromboembolic events * On oral anticoagulants (not includi…