HB2198 for adults with moderate to severe lupus, including lupus nephritis and extra‑renal lupus
A Phase 1, Open Label Dose Escalating Study of HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody With Dual Fc Domains, in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
This trial will test whether two intravenous doses of HB2198 can safely reduce B cells and improve disease measures in adults with moderate to severe lupus, including lupus nephritis and extra‑renal lupus.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hinge Bio Industry-sponsored |
| Locations | 1 site (Brisbane) |
| Trial ID | NCT07491900 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1, open‑label, modified 3+3 dose‑escalation trial of HB2198, a tetravalent bispecific anti‑CD19/CD20 antibody engineered for enhanced B‑cell depletion and optimized Fc effector function. Sequential cohorts of about 30 participants will receive two intravenous doses on Day 1 and Day 8 and be followed for approximately 12 months. The study will collect safety, dose‑limiting toxicity, pharmacokinetics, pharmacodynamics, immunogenicity, and biomarker data, and will measure B‑cell depletion and clinical activity using SLEDAI‑2K, PGA, LupusQoL, FACIT Fatigue, and renal response metrics. Results from this early phase will guide dose selection and inform whether further trials are warranted.
Who should consider this trial
Good fit: Adults with moderate to severely active SLE (SLEDAI‑2K ≥6 and PGA ≥1), including biopsy‑confirmed active class III/IV±V or class V lupus nephritis with proteinuria ≥0.8 g/g and eGFR ≥30 mL/min/1.73 m², or extra‑renal lupus not responding to or intolerant of standard therapies who meet required laboratory and contraceptive/pregnancy criteria are the intended candidates.
Not a fit: Patients with mild disease, severe renal impairment (eGFR <30 mL/min/1.73 m²), inadequate immune cell counts or immunoglobulins, pregnancy, or other exclusions in the protocol are unlikely to be eligible or to benefit from this Phase 1 intervention.
Why it matters
Potential benefit: If successful, HB2198 could offer a new B‑cell‑targeted therapy that more effectively depletes pathogenic B cells and improves lupus symptoms and kidney outcomes.
How similar studies have performed: B‑cell‑targeted therapies such as anti‑CD20 agents have shown benefit for some lupus patients, but dual CD19/CD20 bispecific antibodies like HB2198 are a novel approach with limited clinical experience to date.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • 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 * Positive ANA (≥1:80) or SLE associated autoantibodies * Required minimum lab values (lymphocytes ≥500/µL, B cells ≥25/µL, ANC ≥1000/mm³, IgG ≥600 mg/dL, etc.) * Women of childbearing potential: negative pregnancy test; contraception required * Voluntary informed consent Exclusion Criteria: * (Key) Inclusion Criteria: * 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 * Positive ANA (≥1:80) or SLE associated autoantibodies * Required minimum lab values (lymphocytes ≥500/µL, B cells ≥25/µL, ANC ≥1000/mm³, IgG ≥600 mg/dL, etc.) * Women of childbearing potential: negative pregnancy test; contraception required * Voluntary informed consent (Key) Exclusion Criteria: * Anti CD19 or anti CD20 therapy within 6 months * Active CNS lupus * Significant cardiovascular, pulmonary, hepatic, or uncontrolled systemic disease * Active infection or recent serious infection * Positive HBV DNA or HCV RNA; HIV infection * Major surgery within 4 weeks * Prior organ or stem cell transplant * Current pregnancy or breastfeeding * Recent IVIg or plasmapheresis (\<3 months) * Live vaccine within 30 days * Any condition judged unsuitable by Investigator
Where this trial is running
Brisbane
- Investigational site — Brisbane, Australia (Recruiting)
Study contacts
- Study coordinator: Joshua Pelham
- Email: joshua.pelham@hingebio.com
- Phone: 1-415-378-4738
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.