Study of Magrolimab Combinations in Participants With Myeloid Malignancies

Exclusion Criteria

• •At least 2 weeks must have elapsed since any prior anti-leukemia agents. Note: Localized non-central nervous system (CNS) radiotherapy, hydroxyurea, and erythroid and/or myeloid growth factors are not criteria for exclusion
• •ECOG performance status of 0 to 2
• •Individuals with LVEF \> 50%, lack of symptomatic congestive heart failure, or clinically significant cardiac arrhythmias
• •Must not have been treated with trastuzumab within 7 months prior to the initiation of study treatment
• •Individuals who have not previously received maximum cumulative doses of anthracyclines and anthracenediones
• •Individuals without degenerative or toxic encephalopathies.
• •Individuals who did not undergo hematopoietic SCT in the past 100 days, are not on immunosuppressive therapy post SCT in the 2 weeks prior to the first dose of study treatment, or have no active clinically significant graft-versus-host disease.
• •Safety Run-in Cohort 3 and Phase 2 Cohort 3 (Post-chemo Maintenance Magrolimab+CC-486):
• •Individuals with histological confirmation of AML by WHO criteria who achieved a complete remission (CR) or CR with incomplete hematologic recovery (CRi) with presence of MRD (MRD positive by flow cytometry assay, defined as ≥ 0.1% detectable MRD) after intensive induction chemotherapy with or without consolidation therapy, prior to starting maintenance therapy for newly diagnosed AML, and who are not candidates for hematopoietic stem cell transplantation (SCT) within 1 year of achievement of initial remission
• •ECOG performance status of 0 to 2
• •Individuals without malabsorption syndrome or other conditions that preclude enteral route of administration
• •Positive serum pregnancy test
• •Breastfeeding female
• •Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient
• •Individuals receiving any live virus vaccine within 4 weeks prior to initiation of study treatments
• •Prior treatment with cluster of differentiation 47 (CD47) or signal regulatory protein alpha (SIRPα) -targeting agents
• •Current participation in another interventional clinical trial
• •Known inherited or acquired bleeding disorders
• •Clinical suspicion of or documented active CNS involvement with AML
• •Individuals who have acute promyelocytic leukemia
• •Significant disease or medical conditions, as assessed by the investigator and sponsor, that would substantially increase the risk: benefit ratio of participating in the study. This includes, but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III-IV
• •Second malignancy, except MDS, treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which individuals are not on active anti-cancer therapies and have had no evidence of active malignancy for over 1 year. Previous hormonal therapy with luteinizing hormone-releasing hormone (LHRH) agonists for prostate cancer and treatment with bisphosphonates and receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitors are not criteria for exclusion
• •* Note: Individuals on maintenance therapy alone who have no evidence of active malignancy for at least ≥ 1 year are eligible.
• •Known active or chronic hepatitis B or C infection or human immunodeficiency virus