NCT07061938 Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease
| NCT ID | NCT07061938 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Acepodia Biotech, Inc. |
| Condition | IgG4 Related Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2027-01-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2026-01-01 with a primary completion date of 2027-01-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07061938 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying IgG4 Related Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07061938 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07061938 currently recruiting?
Yes, NCT07061938 is actively recruiting participants. Contact the research team at clinical@acepodiabio.com for enrollment information.
Where is the NCT07061938 trial being conducted?
This trial is being conducted at Atlanta, United States, Boston, United States, Kahoku-gun, Japan.
Who is sponsoring the NCT07061938 clinical trial?
NCT07061938 is sponsored by Acepodia Biotech, Inc.. The trial plans to enroll 30 participants.