Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease
NCT ID: NCT07061938
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2026-01-01
2027-06-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm trial
The single, open label study arm includes 3 dose escalation cohorts:
* Cohort 1:
* Cohort 1a: Receives ACE1831 (Dose Level 1) with lymphodepletion conditioning (LDC)
* Cohort 1b: Receives ACE1831 (Dose Level 1) without LDC.
* Cohort 2: Receives ACE1831 (Dose Level 2) with or without LDC depending on assignment
* Cohort 3: Receives ACE1831 (Dose Level 3) with or without LDC depending on assignment
ACE1831
ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort.
Lymphodepleting chemotherapy
Subjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy cyclophosphamide ahead of ACE1831 administration.
Interventions
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ACE1831
ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort.
Lymphodepleting chemotherapy
Subjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy cyclophosphamide ahead of ACE1831 administration.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Acepodia Biotech, Inc.
INDUSTRY
Responsible Party
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Locations
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Emory University
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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John Varghese
Role: primary
Grace McMahon
Role: primary
Other Identifiers
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ACE1831-201
Identifier Type: -
Identifier Source: org_study_id