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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAcepodia Biotech, Inc.

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • ACE1831
  • Lymphodepleting chemotherapy

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators