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.
In Phase I of the CYNK-001 study for COVID-19, the safety and efficacy of multiple doses of CYNK-001 (administered on days 1, 4 and 7) are being tested with inpatient and outpatient adults (target sample size of 14). Primary outcome measures include the following:
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), with the following primary outcomes:
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
- Banner Health in Phoenix, AZ
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.