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)
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.
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.
Parallel
ACE1831
DrugACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort.
Lymphodepleting chemotherapy
DrugSubjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy (fludarabine and cyclophosphamide) ahead of ACE1831 administration.
Safety and Tolerability of ACE1831 as Assessed by Adverse Events, Clinical Laboratory Tests, Physical Examinations, ECGs, and Vital Signs
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
To assess the efficacy of ACE1831 (primary efficacy)
• Proportion of subjects in complete remission 24 weeks after first dose of ACE1831
3.1 To assess the efficacy of ACE1831 (secondary efficacy): Proportion of subjects who experience sustained complete remission
Proportion of subjects who experience complete remission 72 weeks after the first dose of ACE1831
3.2 To assess the efficacy of ACE1831 (secondary efficacy): Time to first confirmed flare
Time (days) from first dose of ACE1831 to first confirmed flare
3.3 To assess the efficacy of ACE1831 (secondary efficacy): Cumulative GC usage
Cumulative GC usage (milligrams) at at 24, 48 and 72 weeks after the first dose of ACE1831
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