Celularity announced today that the independent Data Monitoring Committee (DMC) completed the first assessment of the ongoing Phase I/II CYNK-001-COVID-19 (CYNKCOVID) study with CYNK-001 off-the-shelf, allogeneic, natural killer (NK) cell therapy in adults with COVID-19.
Celularity announced today that the first patient was dosed in a Phase I/II study of human placental hematopoietic stem cell derived NK cells (CYNK-001) for the treatment of adults with COVID-19 as part of a national clinical trial. The patient was treated at UC Irvine in California, the first CA site to open for patient enrollment with support from a COVID-19 Project grant awarded to Celularity by the California Institute for Regenerative Medicine (CIRM). Participating trial sites include Hackensack University Medical Center and Atlantic Health in New Jersey, MultiCare Health System in Washington State, Banner University Medical Center Phoenix in Arizona, the University of Arkansas in Arkansas, and UC Davis in California. The Principal Investigator is Corey Casper, M.D., MPH, of the Infectious Disease Research Institute (IDRI) ClinicalTrials.gov Identifier: NCT04365101.
Celularity today announced that it has been awarded a $750,000 COVID-19 Project grant by the California Institute for Regenerative Medicine (CIRM), one of the three clinical awards targeting the coronavirus. This grant will support California Institutions participating in the Phase I/II clinical trial of human placental hematopoietic stem cell derived natural killer (NK) cells (CYNK-001) for the treatment of adults with COVID-19.
The expanded strategic collaboration includes the use of Celularity's proprietary CYNK-001 for treatment of SARS-CoV-2 virus, which causes COVID-19 and Acute Respiratory Distress Syndrome
The FDA cleared an investigational new drug application for CYNK-001 for the treatment of adults with COVID-19 infection, according to the agent’s manufacturer.
Celularity Announces Positive DMC Safety Review and Continuation of its Phase I/II CYNK-001-COVID-19 (CYNKCOVID) Study
Celularity Doses First Patient in Clinical Trial Evaluating CYNK-001 in COVID-19 Patients
Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Award to Advance Treatments for COVID-19
Celularity Expands Strategic Collaboration with United Therapeutics Corporation to COVID-19 Infection and Acute Respiratory Distress Syndrome
Celularity Announces FDA Clearance of IND Application for CYNK-001 in Coronavirus, First in Cellular Therapy
Celularity Gets FDA Approval, Moves Toward New Coronavirus Treatment
FDA clears IND application for natural killer cell-based COVID-19 therapy