A Study of Natural Killer Cells in Combination With Atezolizumab in People With Acute Myelogenous Leukemia

Exclusion Criteria

• •Prior allogeneic hematopoietic cell transplantation.
• •Subjects with active/uncontrolled CNS leukemia. Subjects with prior CNS disease must have no detectable evidence of CSF disease for at least 4 weeks prior to enrollment.
• •Subjects requiring systemic immunosuppression for any indication are excluded.
• •Significant cardiovascular disease, as defined by:
• •* New York Heart Association Class II or greater congestive heart failure.
• •* Myocardial infarction, cerebrovascular accident, or other arterial vascular disease within 6 months prior to initiation of study treatment
• •* Unstable arrhythmia
• •* Unstable angina
• •Subjects with isolated extramedullary disease without evidence of bone marrow involvement by immunohistochemistry.
• •Female patients who are pregnant or breast-feeding or intend to become pregnant during study treatment or within 5 months after the final dose of atezolizumab. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment with atezolizumab.
• •Severe or uncontrolled infection prior to initiation of study treatment.
• •Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment, excluding prophylactic antimicrobial agents.
• •History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
• •Uncontrolled or symptomatic hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \>12 mg/dL, or corrected calcium greater than ULN)
• •Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, anti-phospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:
• •* Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
• •* Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
• •* Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all following conditions are met:
• •* Rash must cover \< 10% of body surface area.
• •* Disease is well controlled at baseline and requires only low-potency topical corticosteroids.
• •* There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.
• •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
• •Persons who do not meet the age and organ function criteria specified above.
• •History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
• •Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation.