Actively Recruiting
Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease
Led by Acepodia Biotech, Inc. · Updated on 2026-02-13
30
Participants Needed
3
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Male or female aged 18 to 75 years
- Active IgG4-Related Disease flare at screening with Responder Index of at least 2, confirmed by symptoms, labs, or imaging
- History of IgG4-Related Disease involving at least two organs/sites, current flare involving at least one 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 from screening through 24 weeks after last ACE1831 dose (no lymphodepleting chemotherapy) or 12 months after last lymphodepleting chemotherapy dose (with lymphodepleting chemotherapy)
- For sites in China only: prior treatment failure to glucocorticoids and at least one immunosuppressive agent
You will not qualify if you...
- Significant conditions impairing ability to receive study treatment or comply
- Predominant fibrosis in affected organs
- Active or latent infections interfering with therapy (including HBV, HCV, HIV, TB, syphilis) or significant recent infection
- Known immunodeficiency state
- NYHA class III or IV heart disease
- Severe allergy or hypersensitivity to monoclonal antibodies or relevant study agents
- Malignancy within 5 years (exceptions per protocol)
- Recent exposure to investigational agents
- Recent B-cell depleting therapy (anti-CD20 or anti-CD19) unless reconstitution per protocol
- Live or attenuated vaccine within 2 months
- Pregnant or breastfeeding
- Inadequate organ function or blood counts per protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
Kanazawa Medical University Hospital
Kahoku-gun, JP, Japan, 920-0293
Actively Recruiting
Research Team
A
Acepodia Clinical Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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