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)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|