Phase 1b2a Open Label Study Evaluating the Safety, Effectiveness, and Persistence of ACE1831 Cell Therapy in Adults with IgG4-Related Disease

What this Trial Is About

Researchers are evaluating ACE1831, an off-the-shelf, allogeneic gamma delta T cell therapy derived from healthy donors, for treating subjects with Immunoglobulin G4 Related Disease IgG4-RD. This open-label, multicenter, single-arm study aims to assess the safety, efficacy, and persistence of ACE1831 in people experiencing active flares of IgG4-RD involving multiple organs. The study is sponsored by Acepodia Biotech, Inc. and includes participants aged 18 to 75 years with elevated serum IgG4 and disease activity confirmed by symptoms, labs, and imaging. Participants receive ACE1831 treatment in one of three dose escalation cohorts. Cohort 1 is divided into two groups one receiving ACE1831 with lymphodepleting chemotherapy cyclophosphamide as preconditioning and one without. Cohorts 2 and 3 receive higher doses of ACE1831 with or without lymphodepletion depending on assignment. The study evaluates the impact of these different dosing strategies and conditioning regimens on treatment outcomes. During the study, participants are closely monitored for safety through adverse event reporting, lab tests, physical exams, ECGs, and vital signs for up to 72 weeks after the last ACE1831 dose. Efficacy is assessed up to 72 weeks post-treatment by measuring remission rates, time to disease flare, glucocorticoid use, and changes in quality of life and disease activity scores. Participants agree to follow detailed schedules including glucocorticoid tapering before treatment and contraception requirements. The total study duration extends through long-term follow-up to evaluate persistence and overall treatment effects.

Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease