NTX-301 in MDS/AML

Inclusion criteria

• . Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before the first study-specific procedure.
• . Men or women ≥18 years with one of the following conditions that is relapsed or refractory to at least one line of therapy:
• . Acute myeloid leukemia as long as with myeloblast percentage in the marrow is ≤ 30% or the peripheral white blood cell count is less than 20,000 cells/μL in the absence of leukoreducing therapy (e.g., hydroxyurea, leukapheresis)
• . MDS classified as intermediate, high, or very high risk by International Prognostic Scoring System-Revised \[IPSS-R\] criteria
• . CMML classified as intermediate-2 or high risk per CMML-specific prognostic scoring system (CPSS) or clinical/molecular CPSS (CPSS-mol) criteria
• . ECOG performance status of 0, 1, or 2
• . Adequate organ function at screening defined as follows \[reasonably minor changes pre-first dose are acceptable if deemed so by the investigator\]:
• . Patients must have recovered to grade 1 or less from prior toxicity or adverse events (exception of myelosuppression - neutropenia, anemia, thrombocytopenia - and alopecia). Note: Participants with treatment-related toxicities that are unlikely to resolve per the investigator may be enrolled on a case-by-case basis after discussion with the medical monitor

Exclusion criteria