Systemic Lupus Erthematosus (SLE)Phase 1NCT07491900
A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
A Phase 1 study testing HB2198 in people with Systemic Lupus Erthematosus (SLE) and Lupus Nephritis (LN), run by Hinge Bio at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erthematosus (SLE), Lupus Nephritis (LN), Extra-renal Lupus (ERL)
- What is being tested?
- HB2198
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 23 Mar 2026to 24 Oct 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- (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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kristen Quigley contact
About this study
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
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.
Read the 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.
- Being tested
- HB2198
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB2198Drug
HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: HB2198 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1, Day 8, Day 14, Day 29
Secondary outcomes (11)
To characterize the pharmacokinetic (PK) profile of HB2198
Concentration of HB2198 and PK parameters such as, area under the concentration versus time curve (AUC)
Measured: 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
Concentration of HB2198 and PK parameters such as maximum drug concentration (Cmax)
Measured: 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
Concentration of HB2198 and PK parameters such as time to maximum plasma concentration (tmax)
Measured: 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)
Proportion of participants developing ADAs
Measured: 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
B cell depletion dynamics (depth, duration, subsets)
Measured: 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
- Change from baseline in SLEDAI 2K
Measured: 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
- Achievement of Lupus Low Disease Activity State (LLDAS)
Measured: 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
- Renal response: CRR/PRR
Measured: Day 29, Month 3, Month 6, Month 9, Month 12
To evaluate change from baseline in systemic lupus disease activity
- Change in LupusQoL
Measured: 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
- Change in FACIT Fatigue scores
Measured: 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
- Change in Physician Global Assessment (PGA)
Measured: Screening, Day 1, Day 14, Day 29, Month 2, Month 3, Month 4, Month 6, Month 9, Month 12/End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start23 Mar 2026 (estimated)
- Primary completion24 Oct 2027 (estimated)
- Study completion24 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erthematosus (SLE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hinge Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491900
- Sponsor's protocol ID
- HB2198-001
- Status last verified
- Mar 2026
- First submitted
- 18 Feb 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is still being actively discussed. A decision will be made during the course of the study.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07491900
- Acronym / sponsor ID
- HB2198-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hinge BioIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2026 (estimated)
- Primary completion
- 24 Oct 2027 (estimated)
- Study completion
- 24 Oct 2028 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HB2198 | Experimental | Drug: HB2198Drug: 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • Meet 2019 ACR / 2023 EULAR SLE classification criteria
Key exclusion criteria (21 listed)
- (Key) Inclusion 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HB2198HB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains | Drug | HB2198 |
Primary outcome
Number of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: Undecided. This is still being actively discussed. A decision will be made during the course of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristen Quigley contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HB2198 in people with Systemic Lupus Erthematosus (SLE) and Lupus Nephritis (LN), run by Hinge Bio at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua Pelham (1-415-378-4738, joshua.pelham@hingebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (time frame: Day 1, Day 8, Day 14, Day 29). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.