A Phase I/II study of human placental hematopoietic stem cell derived natural killer cells (CYNK-001) for the treatment of adults with COVID-19
The purpose of this study is to assess the safety of CYNK-001 and to test the effects of CYNK-001 on people with COVID-19. The study plans to find out the best dose of CYNK-001 and to find out if CYNK-001 improves or worsens the disease.
Study participation will last approximately up to one year from the first dose of the CYNK-001 infusion. Approximately 86 subjects will participate across all sites.
CYNK-001 is an investigational product that is a liquid containing natural killer cells (NK cells) taken from human placenta cells. Natural Killer cells are a type of immune cell that can kill cancer cells in some cases. Laboratory tests have shown that CYNK- 001 has the ability to specifically kill the tumor cells without killing normal healthy cells. Natural killer cells can also identify cells infected by some viruses.
CYNK-001 is made from human placental stem cells (cells that create different types of blood cells). These are gathered through the umbilical cord after the birth of healthy full-term babies. The gathered material is carefully screened.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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):
NCT04365101
IDRI
(206)858-6013
CYNK-001-COVID-19@idri.org
Erica Rave, MS
(908)845-4338
erica.rave@celularity.com
Banner University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
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UC Irvine
Irvine, California, United States, 92697
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UC Davis
Davis, California, United States, 95616
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Scripps Health
La Jolla, California, United States, 92037
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Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
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Atlantic Health
Morristown, New Jersey, United States, 07960
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Atlantic Health
Summit, New Jersey, United States, 07901
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
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Multicare Health System
Tacoma, Washington, United States, 98405
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