IgG4 Related DiseasePhase 1/2NCT07061938
Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease
A Phase 1/2 study testing ACE1831 and Lymphodepleting chemotherapy in people with IgG4 Related Disease, run by Acepodia Biotech, Inc. at 11 sites in 3 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgG4 Related Disease
- What is being tested?
- ACE1831 and Lymphodepleting chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 1 Jan 2026to 20 Sep 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
11 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 3 countries
China8 sites, 8 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing
- Recruiting
Peking Union Medical College Hospital
Beijing
- Recruiting
Sichuan University - West China Hospital
Chengdu
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
- Recruiting
The First Affiliated Hospital-University of Science and Technology of China
Hefei
- Recruiting
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai
- Recruiting
Bethune Hospital Shanxi Academy of Medical Sciences
Taiyuan
- Recruiting
Huazhong University of Science and Technology-Tongji Hospital (TJH)
Wuhan
United States2 sites, 2 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Japan1 site, 1 recruiting
- Recruiting
Kanazawa Medical University Hospital
Kahoku-gun, JP, 920-0293
About this study
Official title: Phase 1b/2a Prospective, Open Label, Multicenter, Two-Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With Immunoglobulin G4-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)
Read the detailed description
ACE1831-201 study is an Open Label, Multicenter, Two Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects with Immunoglobulin G4-Related Disease
- Conditions
- IgG4 Related Disease
- Being tested
- ACE1831, Lymphodepleting chemotherapy
- Keywords
- IgG4 Related Disease, cell therapy, IgG4-RD, ACE1831
- Medical subject headings
- Immunoglobulin G4-Related Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE1831Drug
ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort.
Lymphodepleting chemotherapyDrug
Subjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy (fludarabine and cyclophosphamide) ahead of ACE1831 administration.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: ACE1831; Drug: 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) Receives: Drug: ACE1831 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 72 weeks post first-ACE1831 dose
Secondary outcomes (10)
To assess the efficacy of ACE1831 (primary efficacy)
- Proportion of subjects in complete remission 24 weeks after first dose of ACE1831
Measured: 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
Proportion of subjects who experience complete remission 72 weeks after the first dose of ACE1831
Measured: up to 72 weeks post-first ACE1831 dose
3.2 To assess the efficacy of ACE1831 (secondary efficacy): Time to first confirmed flare
Time (days) from first dose of ACE1831 to first confirmed flare
Measured: up to 72 weeks post-first ACE1831 dose
3.3 To assess the efficacy of ACE1831 (secondary efficacy): Cumulative GC usage
Cumulative GC usage (milligrams) at at 24, 48 and 72 weeks after the first dose of ACE1831
Measured: up to 72 weeks post-first ACE1831 dose
3.4 To assess the efficacy of ACE1831 (secondary efficacy): Changes in SF-12
Changes in Quality of Life Questionnaire (QOL) Short Form 12 (SF-12) total score
Measured: up to 72 weeks post-first ACE1831 dose
3.5 To assess the efficacy of ACE1831 (secondary efficacy): Changes in PGA
Changes in Physician's Global Assessment (PGA) of disease activity score (Visual Activity Score, scale range 0 -100)
Measured: up to 72 weeks post-first ACE1831 dose
3.6 To assess the efficacy of ACE1831 (secondary efficacy): Time to PGA = 0
Time (days) to PGA assessment score of 0
Measured: up to 72 weeks post first-ACE1831 dose
3.7 To assess the efficacy of ACE1831 (secondary efficacy): Changes in SGA
Changes in Subject's Global Assessment (SGA) of disease activity score (Visual Activity Score, scale range 0 - 100)
Measured: up to 72 weeks post first-ACE1831 dose
3.8 To assess the efficacy of ACE1831 (secondary efficacy): Changes in SSI
Changes in IgG4-RD symptom severity index (IgG4-RD-SSI) score
Measured: up to 72 weeks post first-ACE1831 dose
3.9 To assess the efficacy of ACE1831 (secondary efficacy): Changes in IgG4-RD RI
Changes in IgG4-RD Responder Index (IgG4-RD RI) score
Measured: up to 72 weeks post first-ACE1831 dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Jan 2026
- Primary completion20 Sep 2029 (estimated)
- Study completion20 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgG4 Related DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acepodia Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061938
- Sponsor's protocol ID
- ACE1831-201
- Status last verified
- Sep 2026
- First submitted
- 27 May 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b/2a Prospective, Open Label, Multicenter, Two-Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With Immunoglobulin G4-Related Disease
- ClinicalTrials.gov ID
- NCT07061938
- Acronym / sponsor ID
- ACE1831-201
- Conditions
- IgG4 Related Disease
- Keywords
- IgG4 Related Disease, cell therapy, IgG4-RD, ACE1831
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Acepodia Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 20 Sep 2029 (estimated)
- Study completion
- 20 Sep 2029 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
ACE1831-201 study is an Open Label, Multicenter, Two Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects with Immunoglobulin G4-Related Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: ACE1831, Drug: Lymphodepleting chemotherapy* 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. |
| Arm B | Experimental | Drug: ACE1831* 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACE1831ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort. | Drug | Arm A, Arm B |
| Lymphodepleting chemotherapySubjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy (fludarabine and cyclophosphamide) ahead of ACE1831 administration. | Drug | Arm A |
Primary outcome
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
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
10 secondary outcomes
To assess the efficacy of ACE1831 (primary efficacy)
Time frame: 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
Time frame: up to 72 weeks post-first ACE1831 dose
3.2 To assess the efficacy of ACE1831 (secondary efficacy): Time to first confirmed flare
Time frame: up to 72 weeks post-first ACE1831 dose
3.3 To assess the efficacy of ACE1831 (secondary efficacy): Cumulative GC usage
Time frame: up to 72 weeks post-first ACE1831 dose
3.4 To assess the efficacy of ACE1831 (secondary efficacy): Changes in SF-12
Time frame: up to 72 weeks post-first ACE1831 dose
3.5 To assess the efficacy of ACE1831 (secondary efficacy): Changes in PGA
Time frame: up to 72 weeks post-first ACE1831 dose
3.6 To assess the efficacy of ACE1831 (secondary efficacy): Time to PGA = 0
Time frame: up to 72 weeks post first-ACE1831 dose
3.7 To assess the efficacy of ACE1831 (secondary efficacy): Changes in SGA
Time frame: up to 72 weeks post first-ACE1831 dose
3.8 To assess the efficacy of ACE1831 (secondary efficacy): Changes in SSI
Time frame: up to 72 weeks post first-ACE1831 dose
3.9 To assess the efficacy of ACE1831 (secondary efficacy): Changes in IgG4-RD RI
Time frame: up to 72 weeks post first-ACE1831 dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ACE1831 and Lymphodepleting chemotherapy in people with IgG4 Related Disease, run by Acepodia Biotech, Inc. at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China, United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Acepodia Clinical Team (415 366 7822, clinical@acepodiabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.