A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)

Who May Qualify: - • Meet 2019 ACR / 2023 EULAR SLE classification criteria - Moderate or high disease activity (SLEDAI 2K ≥6; PGA ≥1) - LN participants: biopsy confirmed active Class III/IV ± V or Class V LN; proteinuria ≥0.8 g/g; eGFR ≥30 mL/min/1.73 m² - ERL participants: inadequate response/intolerance to ≥1 standard SLE therapy - Positive ANA (≥1:80) or SLE associated autoantibodies - Required minimum lab values (lymphocytes ≥500/µL, B cells ≥25/µL, white blood cell count (ANC) at least 1000/mm³, IgG ≥600 mg/dL, etc.) - Women of childbearing potential: negative pregnancy test; contraception required - Voluntary willing to sign a consent form Who Should NOT Join This Trial: - (Key) Who May Qualify: - Meet 2019 ACR / 2023 EULAR SLE classification criteria - Moderate or high disease activity (SLEDAI 2K ≥6; PGA ≥1) - LN participants: biopsy confirmed active Class III/IV ± V or Class V LN; proteinuria ≥0.8 g/g; eGFR ≥30 mL/min/1.73 m² - ERL participants: inadequate response/intolerance to ≥1 standard SLE therapy - Positive ANA (≥1:80) or SLE associated autoantibodies - Required minimum lab values (lymphocytes ≥500/µL, B cells ≥25/µL, white blood cell count (ANC) at least 1000/mm³, IgG ≥600 mg/dL, etc.) - Women of childbearing potential: negative pregnancy test; contraception required - Voluntary willing to sign a consent form (Key) Who Should NOT Join This Trial: - Anti CD19 or anti CD20 therapy within 6 months - Active CNS lupus - Significant cardiovascular, pulmonary, hepatic, or uncontrolled systemic disease - Active infection or recent serious infection - Positive HBV DNA or HCV RNA; HIV infection - Major surgery within 4 weeks - Prior organ or stem cell transplant - Current pregnancy or breastfeeding - Recent IVIg or plasmapheresis (\<3 months) - Live vaccine within 30 days - Any condition judged unsuitable by Investigator Always talk to your doctor about whether this trial is right for you.