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)
|ClinicalTrials.gov Identifier: NCT02781467|
Recruitment Status : Terminated (Business Decision)
First Posted : May 24, 2016
Last Update Posted : March 1, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myeloid, Acute||Biological: PNK-007 Drug: Cyclophosphamide Drug: Fludarabine Drug: Human recombinant Interleukin-2 (rhIL-2)||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Multicenter, Open-Label, Dose Escalating 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).|
|Actual Study Start Date :||July 11, 2016|
|Actual Primary Completion Date :||December 7, 2017|
|Actual Study Completion Date :||December 7, 2017|
Experimental: Cyclophosphamide + Fludarabine + PNK-007 + rhIL-2
Fludarabine Day -6 to -2 and Cyclophosphamide Day -5 and -4. On Day 0 PNK-007 at 4 varying dose levels followed by Human recombinant Interleukin-2 (rhIL-2) every other day, Day 0 to Day 10.
Drug: Human recombinant Interleukin-2 (rhIL-2)
- Dose-Limiting Toxicity (DLT) [ Time Frame: Up to approximately 28 days ]Number and severity of adverse events within 28 days of administration.
- Maximum Tolerated Dose (MTD) [ Time Frame: Up to approximately 28 days ]The maximum dose safely administered for the treatment of patients with AML.
- Adverse Events (AEs) [ Time Frame: Up to approximately 12 months ]Number and severity of adverse events
- Complete remission with incomplete platelet recovery (CRp) [ Time Frame: Up to approximately 42 days ]CRp is defined as leukemia clearance (< 5% marrow blasts and no circulating peripheral blasts) and neutrophil recovery but with incomplete platelet recovery.
- Complete remission (CR) [ Time Frame: Up to approximately 42 days ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781467
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, New Jersey|
|John Theurer Cancer Center at Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|
|United States, New York|
|Roswell Park Cancer Center|
|Buffalo, New York, United States, 14263|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Tennessee|
|Vanderbilt Univ Medical Center|
|Nashville, Tennessee, United States, 37232-6307|
|United States, Wisconsin|
|Froedtert Hospital BMT Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226-3522|
|Study Director:||Monica E Luchi, MD||Celularity Incorporated|