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