This study will find the highest acceptable treatment dose of cord blood, culture expanded natural killer (NK) cells, a kind of immune cell, in patients with relapsed and/or refractory acute myeloid leukemia. The NK cells will be given with chemotherapy and Recombinant human interleukin 2 (rhIL-2) to help the NK cells expand in the body. The safety of this treatment will be studied and researchers want to learn if NK cells will help in treating the AML.
The primary objective of the study is to assess safety and determine the maximum tolerated dose of PNK-007 in subjects with relapsed and/or refractory acute myeloid leukemia (AML). The secondary objective is to explore the potential clinical efficacy by day 42. Treatment plan includes conditioning with cyclophosphamide and fludarabine. PNK-007 will administered IV followed by a total of six Recombinant human interleukin 2 (rhIL-2) injections to support the NK cells in the body. Subjects will be followed for up to 24 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Cancer Center
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Vanderbilt Univ Medical Center
Nashville, Tennessee, United States
Froedtert Hospital BMT Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Dose-Limiting Toxicity (DLT)
Number and severity of adverse events within 28 days of administration.
Time frame: Up to approximately 28 days
Maximum Tolerated Dose (MTD)
The maximum dose safely administered for the treatment of patients with AML.
Time frame: Up to approximately 28 days
Adverse Events (AEs)
Number and severity of adverse events
Time frame: Up to approximately 12 months
Complete remission with incomplete platelet recovery (CRp)
CRp is defined as leukemia clearance (\< 5% marrow blasts and no circulating peripheral blasts) and neutrophil recovery but with incomplete platelet recovery.
Time frame: Up to approximately 42 days
Complete remission (CR)
CR is defined as leukemia clearance (\< 5% marrow blasts, no circulating peripheral blasts) in conjunction with normal values for absolute neutrophil count (\> 1000/μL) and platelet count (\> 100,000/μL), and independence from red cell transfusion.
Time frame: Up to approximately 42 days
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