NCT07491900

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
29mo left

Started Mar 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Mar 2026Oct 2028

First Submitted

Initial submission to the registry

February 18, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 23, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2028

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

February 18, 2026

Last Update Submit

March 18, 2026

Conditions

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

Outcome Measures

Primary Outcomes (4)

  • Number of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

    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.

    Day 1, Day 8, Day 14, Day 29

  • Maximum tolerated dose (MTD)

    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.

    Day 1, Day 8, Day 14, Day 29

  • Number of participants experiencing dose-limiting toxicities (DLTs)

    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.

    Day 1, Day 8, Day 14, Day 29

  • Recommended Phase 2 Dose (RP2D)

    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.

    Day 1, Day 8, Day 14, Day 29

Secondary Outcomes (11)

  • To characterize the pharmacokinetic (PK) profile of HB2198

    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

    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

    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)

    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

    Screening, Day 1, Day 8, Day 14, Day 29, Month 2, Month 3, Month 6, Month 9, Month 12/End of Study

  • +6 more secondary outcomes

Study Arms (1)

HB2198

EXPERIMENTAL

Drug: HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains administered via IV infusion on Day 1 and Day 8. There are 8 Planned dose levels: 0.1 mg/kg → 16 mg/kg

Drug: HB2198

Interventions

HB2198DRUG

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

HB2198

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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
  • 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

You may not qualify 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
  • 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
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational site

Brisbane, Australia

RECRUITING

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Joshua Pelham

CONTACT

1-415-378-4738joshua.pelham@hingebio.com

Kristen Quigley

CONTACT

kristen.quigley@hingebio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2026

First Posted

March 25, 2026

Study Start

March 23, 2026

Primary Completion (Estimated)

October 24, 2027

Study Completion (Estimated)

October 24, 2028

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations

AU(1)