Recruiting NCT07491900

A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)

Phase I Interventional Systemic Lupus Erthematosus (SLE) Lupus Nephritis (LN) Extra-renal Lupus (ERL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: HB2198.
Who it may be relevant to: Registry conditions: Systemic Lupus Erthematosus (SLE), Lupus Nephritis (LN), Extra-renal Lupus (ERL). Basic parameters: 18 years — 65 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Australia
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

HB2198 is a novel tetravalent bispecific antibody engineered for enhanced B-cell depletion through dual CD19/CD20 targeting and optimized Fc mediated effector function. The study uses a modified 3+3 dose escalation design, enrolling sequential cohorts to receive HB2198 IV on Day 1 and Day 8. Safety, dose limiting toxicities, pharmacokinetics, pharmacodynamics, and immunogenicity will be assessed. Participants will undergo comprehensive disease activity assessments using SLEDAI 2K, PGA, LupusQoL, FACIT Fatigue, and renal response metrics. Total participation is about 13 months.

Interventions

Drug HB2198
HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains

Primary outcome measures

Number of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [Time frame: Day 1, Day 8, Day 14, Day 29]
Maximum tolerated dose (MTD) [Time frame: Day 1, Day 8, Day 14, Day 29]
Number of participants experiencing dose-limiting toxicities (DLTs) [Time frame: Day 1, Day 8, Day 14, Day 29]
Recommended Phase 2 Dose (RP2D) [Time frame: Day 1, Day 8, Day 14, Day 29]

Secondary outcome measures (11)

To characterize the pharmacokinetic (PK) profile of HB2198 [Time frame: Multiple timepoints collected before and after infusion on dosing days (Day 1, Day 8), and during the follow-up period on Day 14, Day 29, Month 3, Month 12]
To characterize the pharmacokinetic (PK) profile of HB2198 [Time frame: Multiple timepoints collected before and after infusion on dosing days (Day 1, Day 8), and during the follow-up period on Day 14, Day 29, Month 3, Month 12]
To characterize the pharmacokinetic (PK) profile of HB2198 [Time frame: Multiple timepoints collected before and after infusion on dosing days (Day 1, Day 8), and during the follow-up period on Day 14, Day 29, Month 3, Month 12]
To evaluate the development of anti-drug antibodies (ADAs) [Time frame: Multiple timepoints collected before and after infusion on dosing days (Day 1, Day 8), and during the follow-up period on Day 14, Day 29, Month 3, Month 12]
To evaluate B-cell depletion and other pharmacodynamic changes [Time frame: Screening, Day 1, Day 8, Day 14, Day 29, Month 2, Month 3, Month 6, Month 9, Month 12/End of Study]
To evaluate change from baseline in systemic lupus disease activity [Time frame: Screening, Day 1, Day 14, Day 29, Month 2, Month 3, Month 4, Month 6, Month 9, Month 12/End of Study]
To evaluate change from baseline in systemic lupus disease activity [Time frame: Screening, Day 1, Day 14, Day 29, Month 2, Month 3, Month 4, Month 6, Month 9, Month 12/End of Study]
To evaluate change from baseline in systemic lupus disease activity [Time frame: Day 29, Month 3, Month 6, Month 9, Month 12]
To evaluate change from baseline in systemic lupus disease activity [Time frame: Screening, Day 1, Day 14, Day 29, Month 2, Month 3, Month 4, Month 6, Month 9, Month 12/End of Study]
To evaluate change from baseline in systemic lupus disease activity [Time frame: Screening, Day 1, Day 14, Day 29, Month 2, Month 3, Month 4, Month 6, Month 9, Month 12/End of Study]
To evaluate change from baseline in systemic lupus disease activity [Time frame: Screening, Day 1, Day 14, Day 29, Month 2, Month 3, Month 4, Month 6, Month 9, Month 12/End of Study]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

Australia · 1 center

Investigational site — Brisbane

Identifiers

NCT: NCT07491900 · HB2198-001

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗