HB2198 for adults with moderate to severe lupus, including lupus nephritis and extra‑renal lupus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Investigational site
  Brisbane, Australia Recruiting

Study contacts

• Study coordinator: Joshua Pelham
• Email: joshua.pelham@hingebio.com
• Phone: 1-415-378-4738

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.