Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 at least 2 of the 3 signs/symptoms of the list below:
  • Fever ≥ 38 C°
  • Cough
  • Positive disease-related chest x-ray
  • 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% with the following specifications:

Phase I: SpO2 ≥ 88%

- Supplemental oxygen is permitted as delivered by nasal cannula and/or face mask.

- Patients who require supplemental oxygen must be between the age of 18 and 72 years.

Phase II: SpO2 ≥ 88%

- Patients must be greater than 18 years of age.

- 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.

- 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 severe asthma and is presently on chronic medications or has a history of other symptomatic pulmonary disease.
  • 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:
  • 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.)
  • 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.)
  • 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:
  • Basal cell carcinoma of the skin
  • Squamous cell carcinoma of the skin
  • Carcinoma in situ of the cervix
  • Carcinoma in situ of the breast
  • 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.
  • Patient must not have a history of unconsciousness or hemoptysis within 2 weeks of signing informed consent form.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Phase I will evaluate the safety and efficacy of multiple doses of CYNK-001 (Days 1,4, and 7) in 14 patients. Phase II will utilize a randomized, open-label design; multiple doses of CYNK-001 will be compared to the control group: Best Supportive Care. Up to 72 patients will be included in the Phase II portion of the study with a 1:1 randomization ratio.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase I
CYNK-001 infusions on Days 1, 4, and 7
  • 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.
Active Comparator
Phase II
Randomized, open label; CYNK-001 infusions on Days 1, 4, and 7 compared to Control Group: Best Supportive Care
  • 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.

Recruiting Locations

Banner University Medical Center Phoenix
Phoenix, Arizona 85006
Contact:
Marilyn Glassberg, MD

More Details

Status
Recruiting
Sponsor
Celularity Incorporated

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.