Natural Killer Cell (CYNK-001) Infusions in Adults With COVID-19 (CYNKCOVID)

May 5, 2026 updated by: Celularity Incorporated

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This Phase 1/2 study evaluated the safety and potential efficacy of CYNK-001, an allogeneic natural killer (NK) cell therapy derived from human placental CD34+ cells, in adult patients with moderate COVID-19. Participants received intravenous infusions of CYNK-001 on Days 1, 4, and 7. CYNK-001 IV infusions administered at an initial desensitizing dose of 150 × 106 cells on Day 1 followed by a dose of 600 × 106 cells on Days 4 and 7 plus best supportive care. The study was designed to include a Phase 1 dose-escalation portion followed by a randomized Phase 2 portion; however, due to early termination, only Phase 1 participants were enrolled and treated.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92697
        • UC Irvine
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Atlantic Health
      • Summit, New Jersey, United States, 07901
        • Atlantic Health
    • Washington
      • Tacoma, Washington, United States, 98405
        • Multicare Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase I
CYNK-001 infusions on Days 1, 4, and 7. CYNK-001 IV infusions administered at an initial desensitizing dose of 150 × 106 cells on Day 1 followed by a dose of 600 × 106 cells on Days 4 and 7 plus 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1: Frequency and Severity of Adverse Events (AE)
Time Frame: From first dose through 28 days after first dose, up to 6 months
Number and severity of treatment-emergent adverse events (TEAEs), assessed according to CTCAE version 5.0. TEAEs were defined as adverse events that started or worsened on or after the first dose of study treatment.
From first dose through 28 days after first dose, up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause Mortality
Time Frame: From first dose through 28 days after first dose, up to 6 months
Number of participants who died from any cause during the study period.
From first dose through 28 days after first dose, up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celularity Incorporated

Collaborators

California Institute for Regenerative Medicine (CIRM)
Access to Advanced Health Institute (AAHI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2020

Primary Completion (Actual)

August 30, 2021

Study Completion (Actual)

February 15, 2023

Study Registration Dates

First Submitted

April 22, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYNK-001-COVID-19
  • CLIN2COVID19-11857 (Other Grant/Funding Number: CALIFORNIA STEM CELL AND GENE THERAPY AGENCY)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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