This is a Phase I open-label dose escalation study of a single infusion of FATE-NK100 and a short course of subcutaneous interleukin-2 (IL-2) administered after lymphodepleting chemotherapy (CY/FLU) in subjects with refractory or relapsed acute myelogenous leukemia (AML). FATE-NK100 is a natural killer (NK) cell product that is enriched for NK cells with an "adaptive", or human cytomegalovirus (CMV)-induced, phenotype. The NK cell product is comprised of peripheral blood (PB) leukocytes sourced from a related donor (HLA-haploidentical or better but not fully HLA-matched) that is seropositive for cytomegalovirus (CMV+), and enriched for adaptive NK cells by depletion of CD3+ (T-lymphocytes) and CD19+ (B-lymphocytes) cells followed by ex-vivo culture expansion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Preparative regimen: * Fludarabine 25 mg/m2 x 5 days start Day -6 * Cyclophosphamide 60 mg/kg x 2 days on Day -5 and -4 Apheresis cell collection (collected from the Donor Day - 8) will be enriched for FATE-NK100 per CMC. IL-2 at 6 million IU subcutaneously (SC) every other day (EOD) for 6 doses with Dose 1 on Day 0 (no sooner than 4 hours post NK cells) and last dose no later than Day +12.
University of Minnesota, Masonic Cancer Center
Minneapolis, Minnesota, United States
Maximum tolerated dose (MTD)
Maximum FATE-NK100 dose which could be given to 3 participants such that not more than 1 participant experienced a DLT.
Time frame: 3 months
Clinical activity by CR/CRp leukemia clearance
Incidence of CRp defined as leukemia clearance (≤5%marrow blasts and no circulating peripheral blasts)
Time frame: Day +42
Clinical activity by CR/CRp neutrophil recovery
Incidence of CRp defined as neutrophil recovery (ANC \>500 cells/microliter) but with incomplete platelet recovery
Time frame: Day +42
In vivo expansion of NK cells
Incidence of in vivo expansion (≥ 100 donor derived NK cells per uL blood) of NK cells
Time frame: Day +14
Treatment Related Mortality (TRM)
Incidence of treatment related mortality (TRM)
Time frame: 6 months
Minimal residual disease (MRD) by bone marrow morphology
Incidence of minimal residual disease (MRD) clearance by bone marrow morphology after NK Cell infusion
Time frame: up to Day 28
Minimal residual disease (MRD) by flow cytometry
Incidence of minimal residual disease (MRD) clearance by flow cytometry after NK Cell infusion
Time frame: up to Day 28
Leukemia free survival (LFS)
Incidence of Leukemia free survival (LFS)
Time frame: 1 year
Overall survival (OS)
Incidence of overall survival (OS)
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.