Natural Killer Cell (CYNK-001) Infusions in Adults With COVID-19 (NCT04365101) | Clinical Trial Compass
TerminatedPhase 1/2
Natural Killer Cell (CYNK-001) Infusions in Adults With COVID-19
Stopped: Lack of enrollment due to COVID treatment options availability.
United States7 participantsStarted 2020-09-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. 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).
. Basal cell carcinoma of the skin
. Squamous cell carcinoma of the skin
. Carcinoma in situ of the cervix
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing both phases — can you find out why it was stopped early, and what that means for what we actually know about the safety of CYNK-001 NK cell infusions for COVID-19?
2Since this was a Phase 1/2 trial primarily measuring the frequency and severity of adverse events, does that mean there isn't yet reliable data on whether this treatment actually helps patients with COVID-19, and how does that uncertainty factor into our decision-making?
3Given that this trial involved infusing donor-derived Natural Killer cells into COVID-19 patients, what kinds of immune-related or infusion reactions were being watched for, and are those risks something I should weigh against available standard treatments?
4Because the trial's recruitment is terminated, are there any other active trials testing NK cell therapies or similar immune-based approaches for severe respiratory infections that might be worth exploring instead?
5How does the early termination of this study affect the overall evidence base for NK cell therapy in COVID-19, and would you recommend sticking with established antiviral or supportive care options given what we currently know?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1: Frequency and Severity of Adverse Events (AE)
Timeframe: From first dose through 28 days after first dose, up to 6 months