NCT07491900 A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
| NCT ID | NCT07491900 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hinge Bio |
| Condition | Systemic Lupus Erthematosus (SLE) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-03-23 |
| Primary Completion | 2027-10-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2026-03-23 with a primary completion date of 2027-10-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07491900 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Systemic Lupus Erthematosus (SLE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07491900 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07491900 currently recruiting?
Yes, NCT07491900 is actively recruiting participants. Contact the research team at joshua.pelham@hingebio.com for enrollment information.
Where is the NCT07491900 trial being conducted?
This trial is being conducted at Brisbane, Australia.
Who is sponsoring the NCT07491900 clinical trial?
NCT07491900 is sponsored by Hinge Bio. The trial plans to enroll 30 participants.
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