Seven sites actively recruiting patients for CYNK-001 COVID-19 therapy trial

October 1, 2020

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 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:

  • 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), with the following primary outcomes:

  • 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

Currently, there are seven sites actively enrolling patients for Phase I:

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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