ACE1831 cell therapy for safety, effectiveness, and persistence in people with IgG4-related disease

Phase 1b/2a Prospective, Open Label, Multicenter, Single Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With Immunoglobulin G4-Related Disease

This trial will test ACE1831, an off-the-shelf gamma delta T cell therapy from healthy donors, to see if it is safe and helps adults with active IgG4-related disease.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Acepodia Biotech, Inc. (Industry-sponsored)
• Locations: 3 sites (Atlanta, Georgia and 2 other locations)
• Trial ID: NCT07061938 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter, single-arm Phase 1/2 trial testing ACE1831, an allogeneic gamma delta T (gdT) cell product, given with lymphodepleting chemotherapy as needed. Adults with active IgG4-related disease involving at least two organs and elevated serum IgG4 are eligible and will be treated at participating centers. The study will monitor safety, clinical response using the IgG4-RD Responder Index, and persistence of the infused cells over time. Sites include major academic centers in the United States and Japan.

Who should consider this trial

Good fit: Adults aged 18–75 with an active IgG4-RD flare, elevated serum IgG4, a history of disease in at least two organs, and the ability to taper glucocorticoids per protocol are the intended participants.

Not a fit: Patients with significant uncontrolled comorbidities, inability to stop steroids as required, single-organ disease, or other exclusion criteria are unlikely to be eligible or to benefit from this therapy.

Why it matters

Potential benefit: If successful, ACE1831 could offer a new off-the-shelf cell therapy option that reduces disease activity and lessens reliance on long-term steroids for people with IgG4-RD.

How similar studies have performed: This approach is relatively novel for IgG4-RD with limited prior data in this disease, though cellular immunotherapies have shown promise in other immune-mediated conditions.

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.

Where this trial is running

Atlanta, Georgia and 2 other locations

• Emory University — Atlanta, Georgia, United States (Recruiting)
• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
• Kanazawa Medical University Hospital — Kahoku-gun, Jp, Japan (Recruiting)

Study contacts

• Study coordinator: Acepodia Clinical Team

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