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New cell therapy trial aims to tame rare autoimmune disease

NCT ID NCT07061938

Disease control Sponsor: Acepodia Biotech, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 trial tests a new treatment called ACE1831 for people with IgG4-related disease, a rare condition where the immune system attacks the body, causing swelling and organ damage. ACE1831 is made from healthy donor cells and given as an infusion. The study will check if it is safe and can help control the disease. About 30 adults with active disease will take part.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 30 people

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

Started

Jan 2026

Expected to finish

Jun 2027

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 75 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: To be eligible for this study, all of the following inclusion criteria must be met: * Signed Informed Consent * Male or female ≥ 18 to 75 years of age * Active IgG4-RD flare at screening with IgG4-RD Responder Index at least 2, confirmed by symptoms, labs, and/or imaging. * History of IgG4-RD involving at least 2 organs/sites, and current flare involves at least 1 organ/site (excluding lymph nodes) requiring treatment. * Elevated serum IgG4 above the upper limit of normal at screening. * Able to receive glucocorticoids for current flare and taper to 0 mg by Day -5. * Contraception agreement per protocol from screening through 24 weeks after last ACE1831 dose (no LDC) or 12 months after last LDC dose (with LDC). * For sites in China only: prior treatment failure to glucocorticoids and at least one immunosuppressive agent. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this trial. * Significant conditions that impair ability to receive study treatment or comply. * Predominant fibrosis in affected organs. * Active/latent infection that would interfere with therapy (including HBV, HCV, HIV, TB, syphilis) or significant recent infection per protocol. * Known immunodeficiency state. * NYHA class III/IV heart disease. * Severe allergy/hypersensitivity to monoclonal antibodies or relevant study agents. * Malignancy within 5 years (protocol exceptions apply). * Recent investigational agent exposure. * Recent B-cell depleting therapy (anti-CD20/anti-CD19) unless reconstitution per protocol. * Live/attenuated vaccine within 2 months. * Pregnant or breastfeeding. * Inadequate organ function/blood counts per protocol.

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Conditions

The condition(s) this trial relates to.

Immunoglobulin G4-Related Disease immunoglobulin G4-related sclerosing disease

As listed by the trial registrant

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

IgG4 related disease

How to take part

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

  1. The places running it

    3 sites in 2 countries. 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

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Kanazawa Medical University Hospital

    RECRUITING

    Kahoku-gun, JP, 920-0293, Japan

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

More trials for these conditions

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