Official Title
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
Brief Summary

This study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in patients with moderate COVID-19 disease.

Active, not recruiting
Coronavirus
Coronavirus Infection
Severe Acute Respiratory Syndrome Coronavirus 2
Pneumonia
Pneumonia, Viral
Lung Diseases
Respiratory Tract Disease
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Disease
Immunologic Disease
ARDS
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-infective Agents
Analgesics
Antimetabolites, Antineoplastic

Biological: CYNK-001

CYNK-001 is an allogeneic off the shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells.

Eligibility Criteria

Patient Inclusion Criteria:

- Patient has confirmed positivity for SARS-CoV-2 as measured by rRT-PCR or other
approved test to detect SAR-CoV-2 per institutional practice.

- Patient is experiencing any symptom/clinical sign of COVID-19 illness or has a
positive disease-related chest x-ray/CT scan at screening.

- Patient is ≥ 18 years of age at the time of signing the Study informed consent form
(ICF).

- Patient understands and voluntarily signs the Study ICF prior to any study-related
assessments/procedures are conducted.

- Patient is willing and able to adhere to the study schedule and other protocol
requirements.

- SpO2 ≥ 88% on room air; oxygen is permitted as delivered by nasal cannula and/or face
mask at any flow rate to achieve this SpO2. Patients must have an SpO2 ≥ 92% if on
supplementary oxygen.

- Ability to be off immunosuppressive drugs for 3 days prior to infusion, unless
clinically indicated. Steroids are permitted if clinically indicated and at the
discretion of the treating physician. If clinically indicated, careful consideration
should be taken regarding the timing and tapering of high-dose steroids.

- Female of childbearing potential (FCBP)* must not be pregnant and agree to not
becoming pregnant for at least 28 days following the last infusion of CYNK-001. FCBP
must agree to use an adequate method of contraception during the treatment period.

- FCBP is a female who: 1) has achieved menarche at some point, 2) has not
undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally
postmenopausal (amenorrhea following cancer therapy does not rule out
childbearing potential) for at least 24 consecutive months (i.e., has had menses
at any time in the preceding 24 consecutive months).

- Male Patients must agree to use a condom during sexual contact for at least 28 days
following the last infusion of CYNK-001, even if he has undergone a successful
vasectomy.

Patient Exclusion Criteria

- Patient requires supplemental oxygen delivered by mechanical ventilation, either
invasive or bilevel positive airway pressure.

- Patient admitted to Intensive Care Unit / Pulmonary Acute Care Unit designated area
with severe pulmonary pneumonia, ARDS or Sepsis.

- Patient is pregnant or breastfeeding.

- Patient has a history of chronic asthma requiring ongoing medical therapy or other
chronic pulmonary disease that, at the discretion of the treating physician, would
contraindicate participation in this study.

- Patient has any other organ dysfunction [Common Terminology Criteria for AEs (CTCAE)
Version 5.0 Grade 3] that will interfere with the administration of the therapy
according to this protocol.

- Patient has inadequate organ function as defined below at time of Treatment
Eligibility Period:

1. Patient has aspartate aminotransferase (AST), alanine aminotransferase (ALT), or
alkaline phosphatase ≥ 5 x the upper limit of normal (ULN). (It is anticipated
that the infection may impact liver.)

2. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2 as calculated
using the Modification of Diet in Renal Disease Study equation (Levey, 2006) or
history of an abnormal eGFR < 60. A decline of > 15 mL/min/1.73 m^2 below normal
in the past year prior to infection. (It is anticipated that the infection may
impact renal function.)

3. Patient has a bilirubin level > 2 mg/dL (unless Patient has known Gilbert's
Syndrome).

- Patient has a known sensitivity or allergy to treatment additives or diluent
substances of dimethyl sulfoxide (DMSO), PlasmaLyte A or human serum albumin (HSA).
Please refer to investigational brochure (IB).

- Patient has active autoimmune disease other than controlled connective tissue disorder
or those who are not on active therapy.

- Patient is immunocompromised, has known human immunodeficiency virus (HIV) positivity,
or has actively been treated with immunosuppressive products prior to being infected
with SARS-CoV-2.

- Patient has known active malignancy, unless the Patient has been free of disease for >
3 years from the date of signing the ICF. Exceptions include the following noninvasive
malignancies:

1. Basal cell carcinoma of the skin

2. Squamous cell carcinoma of the skin

3. Carcinoma in situ of the cervix

4. Carcinoma in situ of the breast

5. Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)

- Detection of other respiratory viruses from mucosal surfaces that would interfere with
the study treatment plan; detection of another respiratory virus is not in itself an
exclusion criteria unless the investigator believes it would interfere with
administration of CYNK-001.

- Patient must not have a history of unconsciousness or hemoptysis within 2 weeks of
signing informed consent form.

- Patients must not have a history of unconsciousness or hemoptysis within 2 weeks of
signing ICF.

- Patients must not have end stage liver disease and/or cirrhosis.

- Patient has any significant medical condition, laboratory abnormality, or psychiatric
illness that would prevent the patient from participating in the study.

- Patient has any condition including the presence of laboratory abnormalities which
places the patient at unacceptable risk if he or she were to participate in the study.

- Patient has any condition that confounds the ability to interpret data from the study.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

UC Irvine
Irvine, California, United States

UC Davis Medical Center
Sacramento, California, United States

Scripps Health
San Diego, California, United States

Hackensack University Medical Center
Hackensack, New Jersey, United States

Atlantic Health
Morristown, New Jersey, United States

Atlantic Health
Summit, New Jersey, United States

Multicare Health System
Tacoma, Washington, United States

Corey Casper, MD MPH, Principal Investigator
Access to Advanced Health Institute (AAHI)

Celularity Incorporated
NCT Number
Keywords
CYNK-001
Coronavirus
Covid-19
SARS-CoV-2
Cell Therapy
NK cells
natural killer cells
CYNKCOVID
CYNK-001-COVID-19
MeSH Terms
Infections
Communicable Diseases
COVID-19
Virus Diseases
Pneumonia
Coronavirus Infections
Respiratory Tract Infections
Severe Acute Respiratory Syndrome
Pneumonia, Viral
RNA Virus Infections
Coronaviridae Infections
Nidovirales Infections
Lung Diseases
Respiratory Tract Diseases
Immune System Diseases