Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease (NCT07061938) | Clinical Trial Compass
RecruitingPhase 1/2
Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease
United States, Japan30 participantsStarted 2026-01-01
Plain-language 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)
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: To be eligible for this study, all of the following inclusion criteria must be met:
* 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 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 exposur…
What they're measuring
1
Safety and Tolerability of ACE1831 as Assessed by Adverse Events, Clinical Laboratory Tests, Physical Examinations, ECGs, and Vital Signs