Celularity allogeneic NK cell therapy new crown completed the first patient drug.

Recently, Cellularity, a new-based derivative company, announced that it had completed its first patient administration at the University of California, Irvine, in a phase I./II clinical trial to study COVID-19 natural killing (NK) cell therapy CYNK-001.
Celularity is an independent company split from Celgene dedicated to the development of experimental anticancer therapies derived from the human placenta, as one of the company's core products, CYNK-001 is an allogeneic, ready-to-use (off-the-shelf), frozen natural killer cell (NK) therapy, derived from placental hematopoietic stem cells, developed for a variety of blood tumors and solid tumors potential treatment.
outbreak, Celularity conducted a study on the treatment of CYNK-001 for neo crown pneumonia.
, the FDA approved CYNK-001's clinical trial application for COVID-19 treatment.
CYNK-001 became the first immunotherapy to be approved by the FDA for clinical trials in adult patients with COVID-19.
Xiaokui Zhang, chief scientific officer of Celularity, said numerous studies have shown that NK cells are strongly activated during any viral infection.
studies have shown that CYNK-001 has the biological activity of a range of NK cells, including the expression of activated and natural cytotoxics (e.g. NKp30, NKp44, and NKp46) of activated subjects (e.g. NKG2D, DNAM-1), which can be combined with stress ligations and viral antigens on infected cells.
, CYNK-001 has also been shown to express cell-dissolved molecule perforated proteins and granulase B, which can kill identified infected cells.
these features suggest that CYNK-001 is expected to benefit COVID-19 patients in terms of limiting SARS-CoV-2 replication and inhibiting disease progression by removing infected cells.
Currently, CYNK-001's Phase I./II. clinical trial has completed its first patient dosing at the University of California, Irvine, and other trial sites include Harkensack University Medical Center and Atlantic Health in New Jersey, MultiCare Health System in Washington State, Baner University Medical Center in Arizona, The University of Arkansas at Arkansas, and the University of California, Davis, California.
, phase I/II clinical trials are expected to recruit 86 adult COVID-19 patients.
I. Phase I is the main objective of evaluating the safety, toerability and effectiveness of multiple intravenous injections (IV) CYNK-001 in COVID-19 patients, with up to three injections to be performed on up to 14 patients within 7 days.
II. Phase II is a random, open-label, multi-site study.
the control group with similar infection levels and receiving the best supportive treatment was treated with multiple doses of CYNK-001, with two common main endpoints.
common primary endpoint is to determine the virological efficacy of CYNK-001 in promoting the removal of SARS-CoV-2 in mucous membrane specimens and/or extrinsic blood.
common primary endpoint is to assess the effects of CYNK-001 treatment on clinical symptoms in patients with COVID-19-related lower respiratory tract infections.
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