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Tests treatment safety and results for IgG4 Related Disease
Official title Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease
ClinicalTrials.gov ID: NCT07061938
What this study is testing
What is ACE1831?
ACE1831 is an investigational medicine, being studied as a potential treatment for igg4 related disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- To be eligible for this study, all of the following 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.
You likely can't join if
- 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.
See the full eligibility criteria
- To be eligible for this study, all of the following 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.
- 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 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.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- Kahoku-gun, JP, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Boston, Massachusetts, United States; Kahoku-gun, JP, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.