A Safety Study of Human Cord Blood Derived, Culture Expanded Natural Killer Cell (PNK-007) Infusion With Subcutaneous Recombinant Human IL-2 (rhIL-2) in Adults With Relapsed and/or Refractory Acute Myeloid Leukemia (AML)

The presence of any of the following will exclude a subject from enrollment:

1. Subject has any significant medical condition, laboratory abnormality, or known psychiatric illness that would prevent the subject from participating in the study.

2. Subject has any condition including the presence of laboratory abnormalities which places the subject at unacceptable risk if he or she were to participate in the study.

3. A subject has any condition that confounds the ability to interpret data from the study.

4. Subject has a body weight exceeding 120kg.

5. Subject has aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase ≥ 2.5 x the upper limit of normal (ULN) at screening.

6. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 at screening calculated using the Modification of Diet in Renal Disease Study equation or history of an abnormal eGFR \< 60 and a decline of \> 15 mL/min/1.73 m2 below normal in the past year.

7. Subject has a bilirubin level \> 2 mg/dL (unless subject has known Gilbert's disease) at screening.

8. Subject has had prior treatment with biologic antineoplastic agents no less than 7 days before PNK-007 infusion and at least 5 half lives. For agents that have known Adverse Events (AEs) occurring beyond 7 days after administration (ie, monoclonal antibodies), this period must be extended beyond the time during which acute AEs are known to occur. An exception to this criteria is hydroxyurea which can be given throughout the Screening/Baseline Period up to the time of the pre-conditioning treatment.

9. Subject has bi-phenotypic acute leukemia.

10. Subject has had a transplant \< 60 days prior to Visit 1 (Screening/Baseline visit).

11. Subject has had treatment for graft-versus-host disease \< 30 days prior to Visit 1 (Screening/Baseline visit).

12. Subject is pregnant or breastfeeding.

13. Subject has new or progressive pulmonary infiltrates or pleural effusion large enough to be detected by chest x-ray or Computed tomography (CT) scan.

14. Subject has active autoimmune disease other than controlled connective tissue disorder or those who are not on active therapy.

15. Subject is HIV positive.

16. Subject has a history of malignancy except primary, secondary, or relapsed Acute myeloid leukemia (AML), or excised and cured non-melanoma skin cancer, or cervical carcinoma in situ that was surgically ablated more than 5 years prior to PNK-007 infusion.

17. Subject has a history of severe asthma and is presently on chronic medications or has a history of other symptomatic pulmonary disease.

18. Untreated chronic infection or treatment of any infection with systemic antibiotics within 2 weeks prior to dosing with PNK-007.

19. Subject has any other organ dysfunction (CTCAE Version 4.03 Grade 3) that will interfere with the administration of the therapy according to this protocol.

20. Subject has a resting left ventricular ejection fraction (LVEF) of \< 35% obtained by echocardiography or multigated acquisition scan (MUGA).

What this study is about