RecruitingPhase 1Phase 2NCT07061938

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

Sponsor

Acepodia Biotech, Inc.

Enrollment

30 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

IgG4-related Disease

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)

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ACE1831 and a drug called Lymphodepleting chemotherapy for people with igg4-related disease. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGACE1831

ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort.

DRUGLymphodepleting chemotherapy

Subjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy cyclophosphamide ahead of ACE1831 administration.

Locations(3)

Emory University

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Kanazawa Medical University Hospital

Kahoku-gun, JP, Japan

View Full Details on ClinicalTrials.gov

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NCT07061938

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