Eight sites actively recruiting patients for CYNKCOVID therapy trial

March 29, 2021

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

In Phase I, the safety, tolerability and efficacy of multiple doses of CYNK-001 (administered on days 1, 4 and 7) are being tested with inpatient adults (target sample size of 14).

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)

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:

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.

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