PMC:7324763 / 48514-49793 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/PMC/sourceid/7324763","sourcedb":"PMC","sourceid":"7324763","source_url":"https://www.ncbi.nlm.nih.gov/pmc/7324763","text":"Therapeutic NK cell products can be thought of as “living drugs” as they generally use either primary NK cells isolated from peripheral blood mononuclear cells (PBMCs) or are generated from stem cell precursors or genetically engineered immortalized human NK cell lines (158). Primary NK cell products are often pre-treated and expanded in vitro with cytokines or via co-culture with target cells before being infused into patients. Patients can also receive immune stimulants [e.g. recombinant IL-2 (159) or IL-15 (160)] with the goal of improving the in vivo activity and persistence of the NK cell products (161) as is being tested in this COVID-19 trial (NCT04344548). The first cell-based investigational drug to be approved by the FDA for clinical testing in COVID-19 patients is an allogeneic, off-the-shelf, cryopreserved NK cell therapy made by Celularity (CYNK-001), originally developed for cancer immunotherapy (162). The trial (NCT04365101) is split into two Phases. Phase I will assess the frequency and severity of adverse events in mild, non-ICU COVID-19 patients (n = 14) following infusion of NK cells derived from placental CD34+ cells. The subsequent Phase II trial will recruit up to 72 patients and include a standard of care comparator at a 1:1 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