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NCT Number: NCT07061938

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

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)

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Key information

Conditions

IgG4 Related Disease Autoimmune Diseases Immune System Diseases Immunoglobulin G4-Related Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Kanazawa Medical University Hospital, Kahoku-gun, JP, Japan

Loading trial locations.

About this study

ACE1831-201 study is an Open Label, Multicenter, Single Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects with Immunoglobulin G4-Related Disease

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

ACE1831

Drug

ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort.

Lymphodepleting chemotherapy

Drug

Subjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy cyclophosphamide ahead of ACE1831 administration.

Primary outcomes

  1. 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 last-ACE1831 dose

    Primary Outcome Measures: Safety and Tolerability of ACE1831. Adverse Events: Incidence of TEAEs, SAEs, AESIs, and DLTs. Clinical Laboratory Abnormalities: Number of subjects with clinically significant abnormalities in protocol-defined clinical laboratory assessments compared with baseline.

    Physical Examination Abnormalities: Number of subjects with clinically significant changes from baseline.

    ECG Abnormalities: Number of subjects with clinically significant ECG changes (PR, QRS, QT/QTcF, heart rate) from baseline.

    Vital Signs Abnormalities: Number of subjects with clinically significant changes from baseline.

    Number of Subjects With Clinically Significant Changes in Vital Signs From Baseline. Number of subjects with clinically significant changes in vital signs, including temperature, respiratory rate, heart rate, blood pressure, and oxygen saturation (SpO₂), compared with baseline.

    For all of the above, Unit of Measure: Number of Subjects

Secondary outcomes

  1. To assess the efficacy of ACE1831 (primary efficacy)

    Time frame: 24 weeks after last dose of ACE1831

    • Proportion of subjects in complete remission 24 weeks after last dose of ACE1831

  2. 3.1 To assess the efficacy of ACE1831 (secondary efficacy): Proportion of subjects who experience sustained complete remission

    Time frame: up to 72 weeks post-last ACE1831 dose

    Proportion of subjects who experience sustained complete remission 72 weeks after last dose of ACE1831

  3. 3.2 To assess the efficacy of ACE1831 (secondary efficacy): Time to first flare

    Time frame: up to 72 weeks post-last ACE1831 dose

    Time (days) from first dose of ACE1831 to first flare

  4. 3.3 To assess the efficacy of ACE1831 (secondary efficacy): Cumulative GC usage

    Time frame: up to 72 weeks post-last ACE1831 dose

    Cumulative GC usage (milligrams) at 24 weeks after the last dose of ACE1831

  5. 3.4 To assess the efficacy of ACE1831 (secondary efficacy): Changes in SF-12

    Time frame: up to 72 weeks post-last ACE1831 dose

    Changes in Quality of Life Questionnaire (QOL) Short Form 12 (SF-12) total score

  6. 3.5 To assess the efficacy of ACE1831 (secondary efficacy): Changes in PGA

    Time frame: up to 72 weeks post-last ACE1831 dose

    Changes in Physician's Global Assessment (PGA) of disease activity score (Visual Activity Score, scale range 0 -100)

  7. 3.6 To assess the efficacy of ACE1831 (secondary efficacy): Time to PGA = 0

    Time frame: up to 72 weeks post last-ACE1831 dose

    Time (days) to PGA assessment score of 0

  8. 3.7 To assess the efficacy of ACE1831 (secondary efficacy): Changes in SGA

    Time frame: up to 72 weeks post last-ACE1831 dose

    Changes in Subject's Global Assessment (SGA) of disease activity score (Visual Activity Score, scale range 0 - 100)

  9. 3.8 To assess the efficacy of ACE1831 (secondary efficacy): Changes in SSI

    Time frame: up to 72 weeks post last-ACE1831 dose

    Changes in IgG4-RD symptom severity index (IgG4-RD-SSI) score

  10. 3.9 To assess the efficacy of ACE1831 (secondary efficacy): Changes in IgG4-RD RI

    Time frame: up to 72 weeks post last-ACE1831 dose

    Changes in IgG4-RD Responder Index (IgG4-RD RI) score

Study contacts

Contact information is provided by the study sponsor or research team.

Acepodia Clinical Team

CONTACT

[email protected]

415 366 7822

Sponsors and collaborators

Lead sponsor

Acepodia Biotech, Inc.

Industry

Registry information

Official study title

Phase 1b/2a Prospective, Open Label, Multicenter, Single Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With Immunoglobulin G4-Related Disease

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2025
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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