NCT07491900RecruitingPhase 1
A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
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
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 18 Feb 2026
- Start date
- 23 Mar 2026
- Primary completion date
- 24 Oct 2027
- Lead sponsor
- Hinge Bio
- Diseases
- Lupus (SLE)
- NCT number
- NCT07491900
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 23 Mar 2026 to the primary completion date, 24 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- (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:
Other
- Active CNS lupus
- Current pregnancy or breastfeeding
- Recent IVIg or plasmapheresis (\<3 months)
Who the study is looking for
- • 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Investigational site Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.