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
Acepodia Biotech, Inc.
30 participants
Jan 1, 2026
INTERVENTIONAL
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
Inclusion Criteria8
- 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 Criteria12
- 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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Interventions
ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort.
Subjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy cyclophosphamide ahead of ACE1831 administration.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07061938