Clinical Trials in Japan / NCT07061938
Recruiting
Phase 1/2
Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease
NCT07061938 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
IgG4 Related Disease
Investigational drug(s) / intervention(s)
ACE1831 →Lymphodepleting chemotherapy
ACE1831: ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort.
Lymphodepleting chemotherapy: Subjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy (fludarabine and cyclophosphamide) ahead of ACE1831 administration.
Study 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
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.
Primary outcome measure(s)
- Safety and Tolerability of ACE1831 as Assessed by Adverse Events, Clinical Laboratory Tests, Physical Examinations, ECGs, and Vital Signs — 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
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| Emory University | Atlanta | Georgia | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 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 |
| The First Affiliated Hospital-University of Science and Technology of China | Hefei | China | Recruiting |
| Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | China | Recruiting |
| Bethune Hospital Shanxi Academy of Medical Sciences | Taiyuan | China | Recruiting |
| Huazhong University of Science and Technology-Tongji Hospital (TJH) | Wuhan | China | Recruiting |
| Kanazawa Medical University Hospital | Kahoku-gun | JP | Recruiting |
Other trials for the same condition
A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease
Active, not recruiting
A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07061938 on ClinicalTrials.gov ↗ ← All trials in Japan