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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• Emory University
  Atlanta, Georgia, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, 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

Study contacts

• Study coordinator: Acepodia Clinical Team
• Email: clinical@acepodiabio.com
• Phone: 415 366 7822

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.