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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllAcepodia Biotech, Inc.
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In plain words

What the trial is, and whether it could suit you

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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: To be eligible for this study, all of the following inclusion criteria must be met: * Signed Informed Consent * Male or female โ‰ฅ 18 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, one immunosuppressive agent and one biologic 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 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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What it tests

  • ACE1831
  • Lymphodepleting chemotherapy
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Where

11 sites
Emory University
Atlanta, United States
Massachusetts General Hospital
Boston, United States
Beijing Friendship Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Sichuan University - West China Hospital
Chengdu, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
The First Affiliated Hospital-University of Science and Technology of China
Hefei, China
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China

โ€ฆand 3 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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