drugset / Trial / NCT05653271

ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies

NCT05653271

Phase 1 Completed 16 enrolled Acepodia Biotech, Inc.
Non-randomizedSequentialOpen-labelTreatment

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 of CD20-expressing B-cell malignancies. The ACE1831-001 study is an open-label, Phase I, first-in-human (FIH) study that aims to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, and efficacy of ACE1831 in patients with CD20-expressing Non-Hodgkin lymphoma.

Timeline

Start
2023-01-21
Primary completion
2026-03-31
Completion
2026-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject ACE1831 Cell therapy
Subject Obinutuzumab Monoclonal antibody
Background Cyclophosphamide Other / unclassified
Background Fludarabine Small molecule