Clinical Trial

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

Recruiting Phase 1
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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.
Trial Details
NCT Number NCT07491900
Lead Sponsor Hinge Bio
Conditions Systemic Lupus Erthematosus (SLE), Lupus Nephritis (LN), Extra-renal Lupus (ERL)
Enrollment 30 participants
Start Date 2026-03-23
Primary Completion 2027-10-24 (estimated)
Study Completion 2028-10-24 (estimated)
Updated on ClinicalTrials.gov 2026-03-25