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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
CYNK-001 is an allogeneic off the shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells.
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
Phase 1: Frequency and Severity of Adverse Events (AE)
Number and severity of adverse events
Time frame: Up to 6 months
Phase 1 Futility Check for go/no decision to move to Phase 2: Rate of clinical improvement
Proportion of patients who improved clinical symptoms as measured by the Ordinal Scale for Clinical Improvement (OSCI)
Time frame: Study Day 15
Phase 2: Time to Clinical Improvement by Ordinal Scale for Clinical Improvement (OSCI)
Time to clinical improvement measured by OSCI
Time frame: Study Day 28
Rate of Clearance of SARS-CoV-2
Proportion of patients with "negative" measurement of COVID-19 by rRT-PCR
Time frame: Study Day 28
Time to Clearance of SARS-CoV-2
Time to clearance of SARS-CoV-2 by rRT-PCR testing of mucousal samples with "negative" measurement of COVID-19 by rRT-PCR
Time frame: Study Day 28
Phase 2: Frequency and Severity of Adverse Events (AE)
Number and severity of adverse events
Time frame: up to 6 months
Overall Clinical Benefit by time to medical discharge
Time to medical discharge as an assessment of overall clinical benefit
Time frame: up to 6 months
Overall Clinical Benefit by hospital utilization
Hospital utilization will be measured as an assessment of overall clinical benefit
Time frame: up to 6 months
Overall Clinical Benefit by measuring mortality rate
Mortality rate will be measured as an assessment of overall clinical benefit
Time frame: up to 6 months
Impact of CYNK-001 on sequential organ failure assessment (SOFA) score
Assess the impact of CYNK-001 on changes in sequential organ failure assessment (SOFA) score.
Time frame: Up to 28 days
Time to Pulmonary Clearance
Time from randomization to the date of disappearance of virus from lower respiratory tract infection (LRTI) specimen where it has previously been found (induced sputum, endotracheal aspirate).
Time frame: Up to 28 days
Rate of Pulmonary Clearance
Proportion of patients who had disappearance of virus from lower respiratory tract infection (LRTI) specimen where it has previously been found.
Time frame: Up to 28 days
Supplemental oxygen-free days
For ventilatory support patients, the days with supplemental oxygen-free.
Time frame: Up to 28 days
Proportion of patients requiring ventilation
Proportion of patients who need invasive or non-invasive ventilation
Time frame: Up to 28 days
Duration of hospitalization
Time from hospitalization to medical discharge
Time frame: Study Day 28
Radiologic Evaluation Score
Chest x-ray and/or CT scan results will be evaluated and scored
Time frame: Study Day 28 and Month 6
All-cause mortality rate
Proportion of patients who died
Time frame: Study Day 28 and Month 6
Time to clinical improvement by NEWS2 Score
Time to clinical improvement measured by NEWS2 Score
Time frame: Study Day 28
Rate of clinical improvement by NEWS2 Score
Proportion of patients who achieved clinical symptom improvement measured by NEWS2 Score
Time frame: Study Day 28
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