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NCT07061938PHASE1, PHASE2Recruiting

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

Acepodia Biotech, Inc.

Start Date

1/1/2026

Completion Date

9/20/2029

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, Two Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects with Immunoglobulin G4-Related Disease

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: To be eligible for this study, all of the following inclusion criteria must be met: * Signed Informed Consent * Male or female ≥ 18 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, one immunosuppressive agent and one biologic 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.

Interventions

DRUG

ACE1831

DRUG

Lymphodepleting chemotherapy

Interested in This Trial?

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Conditions

IgG4 Related Disease

Locations

Emory University

Atlanta, Georgia 30322

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Beijing Friendship Hospital

Beijing,

China

Peking Union Medical College Hospital

Beijing,

China

Sichuan University - West China Hospital

Chengdu,

China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou,

China

The First Affiliated Hospital-University of Science and Technology of China

Hefei,

China

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai,

China

Bethune Hospital Shanxi Academy of Medical Sciences

Taiyuan,

China

Huazhong University of Science and Technology-Tongji Hospital (TJH)

Wuhan,

China

Kanazawa Medical University Hospital

Kahoku-gun, JP 920-0293

Japan