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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    86
  • sponsor
    Celularity Incorporated
Updated on 10 May 2021
ct scan
antibiotic therapy
antibiotics
fever
cancer
hysterectomy
immunosuppressant
immunosuppressive
chest x-ray
oophorectomy
x-rays
covid-19
SARS
cough

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.

Details
Condition Coronaviridae Infections, Coronavirus Infection, Pulmonary Disease, Anti-Infective Agents, Antiviral Agents, Physiological Effects of Drugs, Disorder of immune system, biological response modifier, Upper respiratory infection, Respiratory Tract Diseases, Pneumonia, ADULT RESPIRATORY DISTRESS SYNDROME, RNA Virus Infections, Nidovirales Infections, Viral pneumonia, Viral infection, Coronavirus, Analgesics, Antimetabolites, Antineoplastic, Throat and Tonsil Infections, Acute Respiratory Distress Syndrome (ARDS), Pneumonia (Pediatric), Lung Disease, Viral Infections, Severe Acute Respiratory Syndrome Coronavirus 2, respiratory tract infection, pneumoniae, pneumonitis, lung inflammation, anti-infectives, anti-infective, anti-infective agent, antiinfective, antiviral drugs, pulmonary diseases, lung diseases, pulmonary disorders, antiviral, antivirals, antiviral drug, respiratory infection, respiratory infections, infections, respiratory, respiratory tract infections, respiratory tract disease, analgesic, analgesic drugs, pain medication, pain killers, analgesic agents, pain medicine, painkillers, anodyne, acute respiratory distress syndrome, ards, immune disorder, immune disorders, immunologic disease, immune dysfunction, immune disease, immun
Treatment CYNK-001
Clinical Study IdentifierNCT04365101
SponsorCelularity Incorporated
Last Modified on10 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Viral infection or Lung Disease or Pneumonia (Pediatric) or Severe Acute Respiratory Syndrome Coronavirus 2 or Pulmonary Disease or Respiratory Tract ...?
Do you have any of these conditions: ADULT RESPIRATORY DISTRESS SYNDROME or anodyne or pneumonitis or Pneumonia or lung diseases or painkillers or immunologic disease or immune dysfunctio...?
Do you have any of these conditions: RNA Virus Infections or respiratory tract infection or pain medicine or painkillers or antivirals or acute respiratory distress syndrome or Pneumonia ...?
Do you have any of these conditions: ards or respiratory infections or analgesic drugs or respiratory infection or biological response modifier or lung diseases or pain medicine or respir...?
Do you have any of these conditions: Coronavirus or acute respiratory distress syndrome or Anti-Infective Agents or Throat and Tonsil Infections or antiviral drug or pain killers or respi...?
Do you have any of these conditions: Anti-Infective Agents or pain killers or anti-infectives or anodyne or antiviral drug or Throat and Tonsil Infections or Severe Acute Respiratory Synd...?
Do you have any of these conditions: antivirals or immune disease or Analgesics or Throat and Tonsil Infections or Acute Respiratory Distress Syndrome (ARDS) or immune disorders or Viral ...?
Do you have any of these conditions: antiviral or Disorder of immune system or Lung Disease or Severe Acute Respiratory Syndrome Coronavirus 2 or analgesic agents or infections, respirato...?
Do you have any of these conditions: analgesic drugs or pneumonitis or immune disorders or immune disease or respiratory infection or infections, respiratory or pain medication or analges...?
Do you have any of these conditions: pain medication or Acute Respiratory Distress Syndrome (ARDS) or pain killers or Coronavirus Infection or antiviral drug or respiratory infection or P...?
Do you have any of these conditions: Pneumonia or Acute Respiratory Distress Syndrome (ARDS) or antiviral drug or anodyne or respiratory tract disease or Viral Infections or lung diseases...?
Do you have any of these conditions: pain medicine or pneumonitis or antiinfective or biological response modifier or ADULT RESPIRATORY DISTRESS SYNDROME or pain killers or respiratory tr...?
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)
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
Patient understands and voluntarily signs the Study ICF prior to any study-related assessments/procedures are conducted
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
Patient is willing and able to adhere to the study schedule and other protocol requirements
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

Exclusion Criteria

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 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 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
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 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
Patients must not have a history of unconsciousness or hemoptysis within 2 weeks of signing ICF
Basal cell carcinoma of the skin
Patients must not have end stage liver disease and/or cirrhosis
Squamous cell carcinoma of the skin
Patient has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study
Carcinoma in situ of the cervix
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
Carcinoma in situ of the breast
Patient has any condition that confounds the ability to interpret data from the study
Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
Patient must not have a history of unconsciousness or hemoptysis within 2 weeks of signing informed consent form
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