This is a multi-institutional Simon's optimal two-stage phase II trial of CD3/CD19 depleted, ALT-803 activated, haploidentical donor NK cells and subcutaneous ALT-803 given after lymphodepleting chemotherapy (CY/FLU) for the treatment of refractory or released acute myelogenous leukemia (AML).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Preparative Regimen: Fludarabine 25 mg/m2 x 5 days start day -6 Cyclophosphamide 60 mg/kg x 2 days on day -5 and -4 ALT-803 Stimulated Donor NK Cells: The apheresis product (collected day -1) will be enriched for NK cells with the large-scale CliniMacs® device (Miltenyi) by depletion of CD3+ cells to remove T-lymphocytes and depletion of CD19+ cells to remove B-lymphocytes. The NK cell enriched product will be stimulated by overnight incubation with 36.1 ng/mL ALT-803 under GMP conditions and infused on day 0. ALT-803 to Facilitate NK Cell Survival and Expansion: ALT-803 at 10 mcg/kg subcutaneously (SC) with the 1st dose administered on day 0 (no sooner than 4 hours post NK cells), day +5 and day +10 for 3 doses total
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Number of Participants With Complete Remission With or Without Incomplete Platelet Recovery
To estimate the rate of complete remission with incomplete platelet recovery (CRp) - defined as leukemic clearance and neutrophil recovery without platelet recovery - by day 42 after the infusion of CD3/CD19 depleted, ALT-803 stimulated, donor NK cells and subcutaneous ALT-803 given after a non-myeloablative preparative regimen for the treatment of refractory or released acute myelogenous leukemia (AML)
Time frame: Day 42 post NK cell infusion
Incidence of in Vivo Expansion ≥100 of Donor Derived NK Cells Per /μl Blood
Number of patients with successful in vivo NK-cell expansion which is defined by measuring an absolute circulating donor-derived NK cell count of ≥100 cells/μl in patient's peripheral blood.
Time frame: Day 14 post NK cell infusion
Number of Participants Experiencing ALT-803 Associated Toxicity
Toxicity will be classified and graded according to NCI's Common Terminology Criteria for Adverse Events V 4.0 (CTCAE)
Time frame: Day 0
Number of Participants Experiencing ALT-803 Associated Toxicity
Toxicity will be classified and graded according to NCI's Common Terminology Criteria for Adverse Events V 4.0 (CTCAE)
Time frame: Day 5
Number of Participants Experiencing ALT-803 Associated Toxicity
Toxicity will be classified and graded according to NCI's Common Terminology Criteria for Adverse Events V 4.0 (CTCAE)
Time frame: Day 7
Number of Participants Experiencing ALT-803 Associated Toxicity
Toxicity will be classified and graded according to NCI's Common Terminology Criteria for Adverse Events V 4.0 (CTCAE)
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Time frame: Day 10
Number of Participants With Treatment Related Mortality
To evaluate the safety of the therapy as measured by rate of treatment related mortality (TRM) at 6 months
Time frame: 6 months post-therapy