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New treatment option for Systemic Lupus Erthematosus (SLE)
Official title A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
ClinicalTrials.gov ID: NCT07491900
What this study is testing
What is HB2198?
HB2198 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for systemic lupus erthematosus (sle).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- (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
See the full eligibility 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) 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
The study team makes the final eligibility decision.
Where it's taking place
- Brisbane, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brisbane, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.