R&D

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

What is the study?

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.

How long will my participation last?

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.

How can I take part in this trial?
MAIN INCLUSION CRITERIA
  • Adults, ≥ 18 years of age
  • Confirmed positive for SARS-CoV-2 as measured by rRT-PCR.
  • Subject is experiencing at least 2 of the 3 symptoms of the list below:
    a. Fever ≥ 38 C°
    b. Cough
    c. Positive disease-related chest x-ray
  • Hospital admission for start of treatment period
MAIN EXCLUSION CRITERIA
  • Not formally admitted to the hospital
  • Admitted to Intensive Care Unit / Pulmonary Acute Care Unit designated area with severe pulmonary pneumonia, ARDS or Sepsis.
  • Pregnant women
  • History of severe asthma and presently on chronic medications or history of other symptomatic pulmonary disease
How does it work?

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

Contacts

IDRI
(206)858-6013
CYNK-001-COVID-19@idri.org

Erica Rave, MS
(908)845-4338
erica.rave@celularity.com

Participating Trial Locations
ARIZONA

Banner University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
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CALIFORNIA

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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NEW JERSEY

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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ARKANSAS

University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
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WASHINGTON

Multicare Health System
Tacoma, Washington, United States, 98405
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Principle Investigator: Corey Casper, MD MPH • IDRI
Corey Casper, M.D., MPH
CEO

At IDRI, Dr. Casper oversees a scientific portfolio of vaccines, therapeutics, and diagnostics that together provide comprehensive solutions to global health problems. Prior to coming to IDRI, Dr. Casper had a long career at the Fred Hutchinson Cancer Research Center as Full Member, Associate Cancer Center Director and Founding Head of Global Oncology. At Fred Hutch, he designed and managed complex projects, including the construction and operation of one of the first comprehensive cancer centers in sub-Saharan Africa and clinical trials of viral diseases / antiviral medications, cancer biologics, and cancer genomics.

In addition to his executive leadership and research activities, Dr. Casper is a committed educator and clinician. He holds an appointment as Professor of Medicine and Global Health at the University of Washington, where he is also the Associate Director of the Center for AIDS Research. Dr. Casper cares for patients with infectious complications of cancer at the Seattle Cancer Care Alliance and the University of Washington Medical Center.

Dr. Casper received his medical degree from Cornell University, completed a residency in Internal Medicine at the University of California – San Francisco, and a fellowship in Infectious Disease at the University of Washington, where he also earned a Masters of Public Health. His work as Principal Investigator of more than $50 million in peer-reviewed grant funding led to key scientific contributions. These include the development and deployment of diagnostic assays for tumor viruses, leadership of multi-phased international clinical trials from conception to publication culminating in FDA licensure, epidemiologic and cost effectiveness analyses, and translational studies of the virologic and immunologic basis of infectious diseases and cancer.

Sponsors and Collaborators