Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ACE1831, Lymphodepleting chemotherapy.
- Who it may be relevant to
- Registry conditions: IgG4 Related Disease. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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)
Detailed description
ACE1831-201 study is an Open Label, Multicenter, Single Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects with Immunoglobulin G4-Related Disease
Interventions
- Drug ACE1831
ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort. - Drug Lymphodepleting chemotherapy
Subjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy cyclophosphamide ahead of ACE1831 administration.
Primary outcome measures
- Safety and Tolerability of ACE1831 as Assessed by Adverse Events, Clinical Laboratory Tests, Physical Examinations, ECGs, and Vital Signs [Time frame: up to 72 weeks post last-ACE1831 dose]
Secondary outcome measures (10)
- To assess the efficacy of ACE1831 (primary efficacy) [Time frame: 24 weeks after last dose of ACE1831]
- 3.1 To assess the efficacy of ACE1831 (secondary efficacy): Proportion of subjects who experience sustained complete remission [Time frame: up to 72 weeks post-last ACE1831 dose]
- 3.2 To assess the efficacy of ACE1831 (secondary efficacy): Time to first flare [Time frame: up to 72 weeks post-last ACE1831 dose]
- 3.3 To assess the efficacy of ACE1831 (secondary efficacy): Cumulative GC usage [Time frame: up to 72 weeks post-last ACE1831 dose]
- 3.4 To assess the efficacy of ACE1831 (secondary efficacy): Changes in SF-12 [Time frame: up to 72 weeks post-last ACE1831 dose]
- 3.5 To assess the efficacy of ACE1831 (secondary efficacy): Changes in PGA [Time frame: up to 72 weeks post-last ACE1831 dose]
- 3.6 To assess the efficacy of ACE1831 (secondary efficacy): Time to PGA = 0 [Time frame: up to 72 weeks post last-ACE1831 dose]
- 3.7 To assess the efficacy of ACE1831 (secondary efficacy): Changes in SGA [Time frame: up to 72 weeks post last-ACE1831 dose]
- 3.8 To assess the efficacy of ACE1831 (secondary efficacy): Changes in SSI [Time frame: up to 72 weeks post last-ACE1831 dose]
- 3.9 To assess the efficacy of ACE1831 (secondary efficacy): Changes in IgG4-RD RI [Time frame: up to 72 weeks post last-ACE1831 dose]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Emory University — Atlanta
- Massachusetts General Hospital — Boston
Japan · 1 center
- Kanazawa Medical University Hospital — Kahoku-gun
Identifiers
NCT: NCT07061938 · ACE1831-201