Recruiting
Phase 1
Phase 2

ACE1831

Sponsor:

Acepodia Biotech, Inc.

Code:

NCT07061938

Conditions

IgG4 Related Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ACE1831

Lymphodepleting chemotherapy

Study Details

Brief 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)

Conditions

IgG4 Related Disease

Study ID

NCT07061938

Start date

Jan 1, 2026

Status verified date

Sep, 2026

Completion date

Sep 20, 2029

Anticipated

Primary completion date

Sep 20, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria: To be eligible for this study, all of the following inclusion criteria must be met:

  • Signed Informed Consent
  • Male or female ≥ 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.

Study Design

Enrollment

34 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

  • Cohort A1: Receives single infusion of ACE1831 (Dose Level 1) with lymphodepletion conditioning (LDC).
  • Cohort A2: Receives single infusion of ACE1831 (Dose Level 2) with LDC.

experimental: Arm B

  • Cohort B1: Receives two infusions of ACE1831 (Dose Level 1) without LDC.
  • Cohort B2: Receives two infusions of ACE1831 (Dose Level 2) without LDC.

  • Cohort E (Expansion): Two infusions of ACE1831 at the dose/regimen selected by the Safety Review Committee (SRC)

Interventions

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 (fludarabine and cyclophosphamide) ahead of ACE1831 administration.

Primary outcome measure

  • Safety and Tolerability of ACE1831 as Assessed by Adverse Events, Clinical Laboratory Tests, Physical Examinations, ECGs, and Vital Signs [ Time Frame: up to 72 weeks post first-ACE1831 dose ]

Central Contacts and Locations

Central contacts

Acepodia Clinical Team

415 366 7822clinical@acepodiabio.com

Locations

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Acepodia Biotech, Inc.

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Keywords

  • IgG4 Related Disease
  • cell therapy
  • IgG4-RD
  • ACE1831

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Acepodia Biotech, Inc. on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.