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New antibody aims to tame lupus by targeting troublemaking cells

NCT ID NCT07491900

Disease control Sponsor: Hinge Bio Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new drug called HB2198 in 30 adults with moderate to severe lupus, including kidney inflammation. The drug is designed to temporarily remove certain immune cells (B cells) that drive the disease. Participants receive two doses and are monitored for a year to check safety and whether lupus activity improves.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

lupus nephritis systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Extra-renal lupus (ERL) Lupus nephritis (LN) Systemic lupus erthematosus (SLE)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Investigational site

    RECRUITING

    Brisbane, Australia

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Other studies related to the condition(s) this trial covers.