A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
A Phase 1, Open Label Dose Escalating Study of HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody With Dual Fc Domains, in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
Hinge Bio
30 participants
Mar 23, 2026
INTERVENTIONAL
Conditions
Summary
This Phase 1, open label, dose escalation study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of HB2198, a tetravalent bispecific anti CD19/CD20 antibody, in adults with moderately to severely active systemic lupus erythematosus (SLE), including lupus nephritis and extra renal lupus. Approximately 30 participants will receive two intravenous doses of HB2198 and be followed for 12 months to assess safety, B cell depletion, disease activity, immunologic biomarkers, and renal outcomes.
Eligibility
Inclusion Criteria16
- • 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, ANC ≥1000/mm³, IgG ≥600 mg/dL, etc.)
- Women of childbearing potential: negative pregnancy test; contraception required
- Voluntary informed consent
- 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, ANC ≥1000/mm³, IgG ≥600 mg/dL, etc.)
- Women of childbearing potential: negative pregnancy test; contraception required
- Voluntary informed consent
Exclusion Criteria11
- 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
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Interventions
HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07491900