Actively Recruiting
A Phase 1 Open Label Dose Escalation Study of HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody, in Adults With Moderately to Severely Active Systemic Lupus Erythematosus
Led by Hinge Bio · Updated on 2026-03-25
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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 mg/kg to 16 mg/kg following a modified 3+3 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 drug's 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.
CONDITIONS
Brief 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 SLE classification criteria
- Have moderate or high disease activity (SLEDAI 2K ≥6; PGA ≥1)
- For 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
- For extra-renal lupus participants: inadequate response or intolerance to at least one standard SLE therapy
- Positive ANA (≥1:80) or SLE-associated autoantibodies
- Meet required minimum lab values (lymphocytes ≥500/µL, B cells ≥25/µL, ANC ≥1000/mm³, IgG ≥600 mg/dL, etc.)
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception
- Provide voluntary informed consent
You will not qualify if you...
- Received anti CD19 or anti CD20 therapy within 6 months
- Have active central nervous system lupus
- Have significant cardiovascular, pulmonary, hepatic, or uncontrolled systemic disease
- Have an active infection or recent serious infection
- Positive for HBV DNA or HCV RNA; HIV infection
- Had major surgery within 4 weeks
- Have prior organ or stem cell transplant
- Are currently pregnant or breastfeeding
- Received recent intravenous immunoglobulin (IVIg) or plasmapheresis within 3 months
- Received a live vaccine within 30 days
- Any condition judged unsuitable by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 week
Participants receive HB2198 drug infusions via IV on Day 1 and Day 8 to evaluate safety, dose tolerance, and pharmacokinetics.
2 infusion visits (Day 1 and Day 8) and 2 follow-up visits (Day 14 and Day 29)
Duration - Up to 12 months
Participants are monitored for safety, pharmacodynamics, and disease activity changes after treatment for up to 12 months.
Visits at Month 2, Month 3, Month 4, Month 6, Month 9, and Month 12/End of Study
Trial Site Locations
Total: 1 location
1
Investigational site
Brisbane, Australia
Actively Recruiting
Research Team
J
Joshua Pelham
K
Kristen Quigley
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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