Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Histological confirmation of AML (ELN 2022 criteria) that relapsed and/or refractory AML or high-risk MDS as defined by International Consortium for MDS (icMDS) 2023 criteria that have received appropriate standard of care therapy, in the opinion of the investigator or declined receipt of these
Organ function/reserve as per the following laboratory criteria:
Hepatic: Aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤2.5 x ULN, and total bilirubin \<2 x ULN (except for study patients with known Gilbert's where 1.5 x UL of the subject's baseline or in the case of suspected Gilbert's syndrome where a maximum total bilirubin level of 4.0 mg/dL is acceptable) for the local laboratory. If due to disease, higher values may be approved after discussion with medical monitor.
Renal: Adequate renal function as defined by calculated creatinine clearance \>50 mL/min for the CLIA certified local laboratory. Creatinine clearance must be calculated by Cockcroft-Gault equation.
You may not be if
Patients without evidence of blood or marrow involvement
Acute promyelocytic leukemia
Symptomatic central nervous system involvement by AML
Clinical signs/symptoms of leukostasis requiring urgent therapy
Active infections
Radiotherapy \<14 days prior to the first day of RPT1G administration
Ongoing complications from prior therapy
Prior or concurrent malignancy
Any other condition, therapy, treatment, or comorbidity that leads the investigator to determine that the study is not in the best interest of the patient
