Loading clinical trials...

RECRUITINGPHASE1/PHASE2

Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease

Phase 1b/2a Prospective, Open Label, Multicenter, Single Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With Immunoglobulin G4-Related Disease

NCT07061938•Acepodia Biotech, Inc.

View on ClinicalTrials.gov

Summary

ACE1831 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment in subjects with Immunoglobulin G4 Related Disease (IgG4-RD)

Detailed Description

ACE1831-201 study is an Open Label, Multicenter, Single Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects with Immunoglobulin G4-Related Disease

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

•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.
+2 more criteria

Locations (3)

Emory University

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Kanazawa Medical University Hospital

Kahoku-gun, JP, Japan

Key Dates

Start Date

January 1, 2026

Primary Completion Date

January 20, 2027

Completion Date

June 20, 2027

Last Updated

February 13, 2026

Enrollment

ESTIMATED participants

Conditions

IgG4 Related Disease

Interventions

ACE1831

DRUG

Lymphodepleting chemotherapy

DRUG

Contacts

Acepodia Clinical Team

CONTACT

415 366 7822 clinical@acepodiabio.com

the Safety and Efficacy of Targeted BCMA In Vivo LV Injection for Recurrent or Refractory Autoimmune Diseases

NCT07339540

Recurrent or Refractory Systemic Lupus ErythematosusRecurrent or Refractory IgG4 Related Diseases+3 more

View study

ACTIVE_NOT_RECRUITINGPHASE3

A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease

NCT04540497

IgG4 Related Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease

Inclusion Criteria

Exclusion Criteria

the Safety and Efficacy of Targeted BCMA In Vivo LV Injection for Recurrent or Refractory Autoimmune Diseases

A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease

Adaptive and Trained Immunity in the Pathogenesis of IgG4-Related Disease