Actively Recruiting
A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
Led by Hinge Bio · Updated on 2026-03-25
30
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet 2019 ACR / 2023 EULAR classification criteria for SLE
- Moderate or high disease activity (SLEDAI 2K 6; PGA 1)
- Lupus nephritis participants: biopsy confirmed active Class III/IV V or Class V LN; proteinuria 0.8 g/g; eGFR 30 mL/min/1.73 m2
- Extra-renal lupus participants: inadequate response or intolerance to at least one standard SLE therapy
- Positive ANA ( 1:80) or SLE associated autoantibodies
- Required minimum laboratory values (lymphocytes 500/L, B cells 25/L, ANC 1000/mm3, IgG 600 mg/dL, etc.)
- Women of childbearing potential must have a negative pregnancy test and use contraception
- Provide voluntary informed consent
You will not qualify if you...
- Received anti-CD19 or anti-CD20 therapy within 6 months prior to study
- Have active central nervous system lupus
- Have significant cardiovascular, pulmonary, hepatic, or uncontrolled systemic disease
- Have active infection or recent serious infection
- Positive for HBV DNA or HCV RNA or have HIV infection
- Underwent major surgery within 4 weeks prior to study
- History of organ or stem cell transplant
- Currently pregnant or breastfeeding
- Received intravenous immunoglobulin or plasmapheresis within 3 months prior to study
- Received live vaccine within 30 days prior to study
- Any condition deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Investigational site
Brisbane, Australia
Actively Recruiting
Research Team
J
Joshua Pelham
CONTACT
K
Kristen Quigley
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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