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

NCT07061938 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ACE1831-201
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of ACE1831 as Assessed by Adverse Events, Clinical Laboratory Tests, Physical Examinations, ECGs, and Vital Signs

  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

  up to 72 weeks post last-ACE1831 dose

Secondary Outcomes (10)

• To assess the efficacy of ACE1831 (primary efficacy)

  24 weeks after last dose of ACE1831

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

  up to 72 weeks post-last ACE1831 dose

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

  up to 72 weeks post-last ACE1831 dose

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

  up to 72 weeks post-last ACE1831 dose

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

  up to 72 weeks post-last ACE1831 dose

Study Arms (1)

Single Arm trial

EXPERIMENTAL

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

Drug: ACE1831; Drug: Lymphodepleting chemotherapy

Interventions

ACE1831 DRUG

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

Single Arm trial

Lymphodepleting chemotherapy DRUG

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

Single Arm trial

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acepodia Biotech, Inc.: lead

Study Sites (3)

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Kanazawa Medical University Hospital

Kahoku-gun, JP, 920-0293, Japan

RECRUITING

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Acepodia Clinical Team

CONTACT

415 366 7822; clinical@acepodiabio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: July 14, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): June 20, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1); US (2)