NCT07061938

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)

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
36mo left

Started Jan 2026

Typical duration for phase_1

Geographic Reach
3 countries

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Jan 2026Sep 2029

First Submitted

Initial submission to the registry

May 27, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2029

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

3.7 years

First QC Date

May 27, 2025

Last Update Submit

September 29, 2026

Conditions

IgG4 Related Disease

Keywords

IgG4 Related Diseasecell therapyIgG4-RDACE1831

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 first-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-first ACE1831 dose

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

    up to 72 weeks post-first ACE1831 dose

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

    up to 72 weeks post-first ACE1831 dose

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

    up to 72 weeks post-first ACE1831 dose

  • +5 more secondary outcomes

Study Arms (2)

Arm A

EXPERIMENTAL

* 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.

Drug: ACE1831Drug: Lymphodepleting chemotherapy

Arm B

EXPERIMENTAL

* 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)

Drug: ACE1831

Interventions

ACE1831DRUG

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

Arm AArm B
Lymphodepleting chemotherapyDRUG

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

Arm A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Beijing Friendship Hospital

Beijing, China

RECRUITING

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Sichuan University - West China Hospital

Chengdu, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

RECRUITING

The First Affiliated Hospital-University of Science and Technology of China

Hefei, China

RECRUITING

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, China

RECRUITING

Bethune Hospital Shanxi Academy of Medical Sciences

Taiyuan, China

RECRUITING

Huazhong University of Science and Technology-Tongji Hospital (TJH)

Wuhan, China

RECRUITING

Kanazawa Medical University Hospital

Kahoku-gun, JP, 920-0293, Japan

RECRUITING

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease

Condition Hierarchy (Ancestors)

Autoimmune DiseasesImmune System Diseases

Central Study Contacts

Acepodia Clinical Team

CONTACT

415 366 7822clinical@acepodiabio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
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)

September 20, 2029

Study Completion (Estimated)

September 20, 2029

Last Updated

October 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)US(2)CN(8)