Clinical Trials in Australia / NCT07491900
Recruiting
Phase 1
A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
NCT07491900 · tracked via the Priya Life Science Australia tracker
Condition(s) studied
Systemic Lupus Erthematosus (SLE)Lupus Nephritis (LN)Extra-renal Lupus (ERL)
Investigational drug(s) / intervention(s)
HB2198
HB2198: HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains
Study 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
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
Primary outcome measure(s)
- Number of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) — Day 1, Day 8, Day 14, Day 29
Safety and tolerability will be assessed primarily by the incidence of TEAEs and SAEs. Supporting safety data (e.g., clinical laboratory values, vital signs, ECG results, physical examinations, and renal function assessments) will be reviewed descriptively to aid interpretation of tolerability but will not be reported as separate outcome measures. - Maximum tolerated dose (MTD) — Day 1, Day 8, Day 14, Day 29
MTD will be determined based on the incidence of dose-limiting toxicities (DLTs) according to protocol-defined criteria. Laboratory results, vital signs, ECGs, physical examinations, and renal assessments will be used to evaluate DLTs but will not be individually reported as outcome measures. - Number of participants experiencing dose-limiting toxicities (DLTs) — Day 1, Day 8, Day 14, Day 29
DLTs will be evaluated based on protocol-defined criteria. Supporting safety data (e.g., labs, vitals, ECGs, physical exams, renal assessments) will be used to determine DLT classification but will not be reported as separate outcome measures. - Recommended Phase 2 Dose (RP2D) — Day 1, Day 8, Day 14, Day 29
The RP2D will be selected using an integrated assessment of DLTs, TEAEs, and overall tolerability, based on protocol-defined safety criteria. Clinical laboratory results, vital signs, ECGs, physical examinations, and renal assessments will be used to inform dose selection but will not be individually reported.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Investigational site | Brisbane | Australia | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07491900 on ClinicalTrials.gov ↗ ← All trials in Australia