This is a phase I/2, interventional, open-label, multicenter study to assess the safety and efficacy of ARD103 in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.
Documented diagnosis of AML with either refractory or relapsed disease or diagnosis of MDS and ≥ 5% BM blasts
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Absolute lymphocyte count (ALC) > 100/mm3
ALT and AST < 3.0 × the ULN
Participants with acute promyelocytic leukemia
Presence of active and clinically relevant central nervous system (CNS) disorder
Autoimmune disease requiring immunosuppressive treatment
Participants with known hepatic bridging cirrhosis
ARCE Therapeutics, Inc.
Lead sponsor