ClinicalTrials.gov record NCT07061938
Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease
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
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This phase 1b/2a open-label study evaluates ACE1831, an off-the-shelf donor-derived gamma delta T cell therapy, in people with IgG4-related disease. There are two experimental arms: Arm A gives a single ACE1831 infusion with lymphodepleting chemotherapy (two dose levels), and Arm B gives two ACE1831 infusions without lymphodepletion (two dose levels), plus an expansion cohort. The study measures safety, disease response, and how long the cells persist, with follow-up up to about 72 weeks.
What it is studying. The study is testing the safety, tolerability, disease activity effects, and persistence of ACE1831, an allogeneic gamma delta T-cell therapy, in people with IgG4-related disease.
What the researchers hope to learn. Scientific goals: assess safety and tolerability (adverse events, labs, exams, ECGs, vital signs); measure efficacy outcomes including proportion in complete remission at 24 weeks and sustained remission at 72 weeks; time to first confirmed flare; cumulative glucocorticoid use; changes in quality of life (SF-12), physician and subject global assessments, symptom severity index, and IgG4-RD Responder Index; and assess persistence of ACE1831 cells.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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)
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- ACE1831
- Lymphodepleting chemotherapy
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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 description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants receive the investigational cell therapy ACE1831 as either one infusion (Arm A) or two infusions (Arm B); some participants in Arm A receive lymphodepleting chemotherapy (fludarabine and cyclophosphamide) before the ACE1831 infusion. The study includes safety monitoring and follow-up for up to about 72 weeks after the first ACE1831 dose, with reporting of adverse events and routine clinical assessments such as clinical laboratory tests, physical exams, ECGs, and vital signs. Disease activity and quality-of-life measures will be collected during visits, including Physician's Global Assessment, Subject's Global Assessment, the IgG4-RD Responder Index, symptom severity index, and the SF-12 questionnaire. The registry record does not describe other participant support services, contact options, or invitations to future research.
How the study is structured. Interventional, non-randomized, open-label, parallel two-arm Phase 1b/2a study. Participants are assigned to cohorts within Arm A (single infusion after lymphodepleting chemotherapy; Dose Levels 1–2) or Arm B (two infusions without lymphodepletion; Dose Levels 1–2), with an additional expansion cohort selected by a Safety Review Committee. There is no masking. Safety and disease-related outcomes are followed for up to about 72 weeks after the first dose.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The listed sites are in China, Japan, United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on IgG4-related disease
Important dates
- Study start
- Jan 1, 2026
- Primary completion
- Sep 20, 2029 (estimated)
- Study completion
- Sep 20, 2029 (estimated)
- Target enrollment
- 34 participants (estimated)
- Last updated on registry
- Oct 2, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Acepodia Biotech, Inc.
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Acepodia Clinical Team 📞 415 366 7822 ✉ clinical@acepodiabio.com
Participating sites (11)
- Emory UniversityRecruiting
Atlanta, Georgia, 30322 · United States
- Massachusetts General HospitalRecruiting
Boston, Massachusetts, 02114 · United States
- Beijing Friendship HospitalRecruiting
Beijing · China
- Peking Union Medical College HospitalRecruiting
Beijing · China
- Sichuan University - West China HospitalRecruiting
Chengdu · China
- The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting
Hangzhou · China
- The First Affiliated Hospital-University of Science and Technology of ChinaRecruiting
Hefei · China
- Renji Hospital Affiliated to Shanghai Jiaotong University School of MedicineRecruiting
Shanghai · China
- Bethune Hospital Shanxi Academy of Medical SciencesRecruiting
Taiyuan · China
- Huazhong University of Science and Technology-Tongji Hospital (TJH)Recruiting
Wuhan · China
Terms used on this page · explanations by MedicalUpdates.ai
- inclusion criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Informed Consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- at screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- upper limit of normal
- The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
- glucocorticoids
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- prior treatment
- Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
- immunosuppressive
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
- investigational agent
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- Open Label
- No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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