Testing HB2198, a new antibody drug, in adults with active lupus
Tests HB2198 for safety in adults with moderately to severely active lupus.
Plain-language title generated from the registry record
Registry title: A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
Key facts
- Where
- Brisbane, AustraliaSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 65 with moderately to severely active systemic lupus erythematosus (SLE), including lupus nephritis and lupus outside the kidneys.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- SLE with moderate or high disease activity (SLEDAI 2K ≥6; PGA ≥1). Lupus nephritis: biopsy-confirmed active Class III/IV ± V or Class V, proteinuria ≥0.8 g/g, eGFR ≥30 mL/min/1.73 m². Lupus outside the kidneys: not enough response to, or could not tolerate, at least 1 standard SLE therapy.
- Earlier treatment
- People with lupus outside the kidneys must have had an inadequate response to, or not tolerated, at least 1 standard SLE therapy. Anti-CD19 or anti-CD20 therapy within 6 months is not allowed.
- Biomarker or test result
- Positive ANA (≥1:80) or SLE-associated autoantibodies. Minimum blood values are required (lymphocytes ≥500/µL, B cells ≥25/µL, ANC ≥1000/mm³, IgG ≥600 mg/dL, among others).
Main reasons for not taking part
- Anti-CD19 or anti-CD20 therapy within 6 months
- Active lupus affecting the central nervous system
- Active infection or recent serious infection; positive HBV DNA or HCV RNA; HIV infection
- Prior organ or stem cell transplant
- Current pregnancy or breastfeeding
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07491900, who can take part
Where in Australia
- BrisbaneBrisbane, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hinge Bio
- Trial code
- NCT07491900
- Record updated
- 25 March 2026
- Original description
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.Read full original descriptionShow less
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 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.
Inclusion: • 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: Anti CD19 or anti CD20 therapy within 6 months; Major surgery within 4 weeks; Prior organ or stem cell transplant; Live vaccine within 30 days; Significant cardiovascular, pulmonary, hepatic, or uncontrolled systemic disease; Active infection or recent serious infection; Positive HBV DNA or HCV RNA; HIV infection; Any condition judged unsuitable by Investigator; (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:; Active CNS lupus; Current pregnancy or breastfeeding; Recent IVIg or plasmapheresis (<3 months).