A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHinge Bio
About this trial
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 criteria
Qualifiers
• 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
Disqualifiers
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
Trial design
Treatments tested in this trial
- HB2198
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
1Investigational site Brisbane Australia
Sponsors and collaborators
Hinge Bio
Lead sponsor
Source ClinicalTrials.gov