Phase 1 Open Label Study of HB2198 IV Treatment in Adults With Moderately to Severely Active Systemic Lupus Erythematosus Including Lupus Nephritis and Extra-renal Lupus

What this Trial Is About

Researchers are evaluating HB2198, a new tetravalent bispecific antibody designed to target CD19 and CD20 for enhanced B-cell depletion in adults with moderately to severely active systemic lupus erythematosus SLE, including lupus nephritis and extra-renal lupus. This Phase 1, open-label, dose escalation study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early clinical effects of HB2198 in about 30 participants. The study addresses the need for improved treatments in this autoimmune condition by carefully monitoring disease activity and immune responses. Participants will receive two intravenous doses of HB2198 on Day 1 and Day 8, with planned dose levels ranging from 0.1 mgkg to 16 mgkg following a modified 33 dose escalation design. The study includes detailed assessments of dose limiting toxicities and immunogenicity. The total participation period is approximately 13 months, including follow-up evaluations to characterize the drugs pharmacokinetics and pharmacodynamics, and to measure disease and renal outcomes. During the study, participants will undergo multiple evaluations including safety monitoring for adverse events at specific days Day 1, 8, 14, 29, and ongoing assessments of lupus disease activity using tools such as SLEDAI 2K, PGA, LupusQoL, and FACIT Fatigue. Laboratory tests will assess B-cell depletion and immunologic biomarkers at various timepoints up to 12 months. The study also monitors renal response and anti-drug antibody development. This comprehensive approach aims to gather safety and early efficacy data to guide future research.

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