A Safety Study of Human Cord Blood Derived, Culture-expanded, Natural Killer Cell (PNK-007) Infusion With or Without Subcutaneous Recombinant Human Interleukin-2 (rhIL-2) Following Autologous Stem Cell Transplant for Multiple Myeloma (MM)
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|ClinicalTrials.gov Identifier: NCT02955550|
Recruitment Status : Active, not recruiting
First Posted : November 4, 2016
Last Update Posted : February 19, 2019
This study will find the highest acceptable treatment dose and timing of infusion of cord blood, culture expanded natural killer (NK) cells, a kind of immune cell, in patients with multiple myeloma.
The NK cells will be given at varying days post autologous stem cell transplant. rhIL-2 is administered after treatment 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 multiple myeloma.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: rhIL-2 Biological: PNK-007||Phase 1|
The primary objective of the study is to assess safety and determine the maximum tolerated dose of PNK-007 as well as the feasibility of treating at various timepoints following ASCT in subjects with multiple myeloma. The secondary objective is to explore the potential clinical efficacy by day 90-100 post ASCT.
Treatment plan includes ASCT followed by PNK-007 which will be administered IV Day 14 post ASCT to determine the maximum tolerated dose. Once the IV Day 14 post ASCT. PNK-007 will be followed by up to six rhIL-2 injections to support the NK cells expansion in the body.
Subjects will be followed for up to 12 months post PNK-007.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Multicenter, Open-label, Safety Study of Human Cord Blood Derived, Culture-expanded, Natural Killer Cell (PNK-007) Infusion Following Autologous Stem Cell Transplant for Multiple Myeloma|
|Actual Study Start Date :||January 5, 2017|
|Estimated Primary Completion Date :||July 31, 2019|
|Estimated Study Completion Date :||July 31, 2019|
Experimental: PNK-007 and rhIL-2
Melphalan per institutional practices (within Day -5 to 01), ASCT (Day 0), PNK-007 at varying dose levels (within Day 7 to Day 14) and rhIL-2 every other day starting day of PNK-007 administration.
Human recombinant Interleukin-2
PNK-007 is a culture-expanded cell population derived from human cord blood hematopoietic stem/progenitor cells.
- Dose-Limiting Toxicity (DLT) [ Time Frame: Up to 28 days ]Number and severity of adverse events within 28 days of administration
- Maximum Tolerated Dose (MTD) [ Time Frame: Up to 28 days ]The maximum dose safely administered for the treatment of patients with multiple myeloma
- Dose Timing After Autologous Stem Cell Transplant [ Time Frame: Up to 28 days ]The optimal dose timing safely administered for the treatment of patients with multiple myeloma post ASCT
- Adverse Events (AEs) [ Time Frame: Up to 12 months ]Number and severity of adverse events within 12 months of administration
- Response Rate [ Time Frame: Up to day 100 ]Clinical efficacy at day 90-100 post ASCT per International Myeloma Working Group criteria, including minimal residual disease
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): NCT02955550
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, Missouri|
|Washington Univ School of Medicine Siteman Cancer Center|
|Saint Louis, Missouri, United States, 63110|
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-6805|
|United States, New Jersey|
|Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Mt. Sinai School of Medicine|
|New York, New York, United States, 10029|
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Study Director:||Monica E Luchi, MD||Celularity Incorporated|