The CYNKCOVID clinical trial involves Phase I/II studies to evaluate human placental hematopoietic stem cell–derived natural killer (NK) cell therapy to treat COVID-19 in hospitalized adults are currently ongoing as part of our partnership with the Infectious Disease Research Institute (IDRI).
NK Cell Therapy
New Jersey-based Celularity’s NK cell therapy (CYNK-001) is an allogeneic off-the-shelf cell therapy enriched for CD56+/CD3-NK cells expanded from human placental CD34+ cells. NK cells are a unique class of immune cells, innately capable of interacting with adaptive immunity. Because they are intrinsically safe and versatile, they can be used across a range of organs and tissues. Prior to studying CYNK-001 as a potential therapy for COVID-19, studies were already underway evaluating it for the treatment of multiple myeloma, acute myeloid leukemia, glioblastoma multiforme and various hematologic cancers and solid tumors.
Study Protocol
- Frequency and severity of adverse events (AEs)
- Proportion of subjects who achieved SARS-CoV-2 clearance, as measured by real-time reverse transcription polymerase chain reaction (rRT-PCR)
- Proportion of subjects with improved clinical symptoms related to lower respiratory tract infection, as measured by the National Early Warning Score 2 (NEWS2) score
Phase II will consist of a randomized, open-label design in which multiple doses of CYNK-001 will be compared with best supportive care (control group) for 72 patients total (1:1 randomization). Efficacy will be assessed using the World Health Organization Ordinal Scale for Clinical Improvement (OSCI)
- Time from the date of randomization to SARS-CoV-2 clearance in nasal and/or lower respiratory tract samples, as measured by rRT-PCR (two negative results required in same sample type)
- Time from the date of randomization to the first date of improved clinical symptoms related to lower respiratory tract infection, as measured by the NEWS2 score
Study Status
The first Data Monitoring Committee (DMC) meeting was held in November, during which there were no safety concerns raised.
Phase I is underway, and there are eight sites actively enrolling patients:
- Hackensack University Medical Center in Hackensack, NJ
- Atlantic Health in Morristown, NJ and Summit, NJ
- Multicare Health System in Tacoma, WA
- University of Arkansas in Fayetteville, AR
- University of California, Irvine in Irvine, CA
- University of California, Davis in Davis, CA
- Scripps Health in San Diego, CA
Strategic site identification is based on FHI Clinical’s Global Strategy Group’s network of sites as well as ongoing evaluation of epidemiology, patient availability at healthcare facilities and site capabilities (both for clinical research and the ability to balance clinical research with patient care). Our site start-up team selects sites and coordinates virtual site evaluation visits. Feasibility to site activation is completed within 3-4 weeks, due to the combination of our proven rapid study start-up process and the acceleration of review processes at the clinical trial sites.
Download our brochure to learn more about our COVID-19 research services.
