US-based Celularity has started dosing participants in a Phase I/II clinical trial of CYNK-001 to treat adults suffering from Covid-19 as part of a national study.
CYNK-001 consists of human placental hematopoietic stem cell-derived NK cells.
The first patient was dosed at UC Irvine in California, US. Enrolment is supported by a COVID-19 Project grant provided to Celularity by the California Institute for Regenerative Medicine (CIRM).
Other participating sites include Hackensack University Medical Center, Atlantic Health, MultiCare Health System, Banner University Medical Center Phoenix, the University of Arkansas, and UC Davis.
Celularity founder, chairman and CEO Robert Hariri said: “Through this collaboration with our partner sites, we were able to rapidly scale and commence what we believe is the first NK cell-based immunotherapy trial targeting Covid-19.
“We are optimistic that the study’s initial findings will demonstrate CYNK-001 as a safe and effective, as well as rapidly deployable and scalable approach to the treatment of Covid-19 patients, giving them the immune cells that are critical in fighting this infection.”
The Phase I/II trial will investigate the safety and clinical efficacy of CYNK-001, determined as clearance of the SARS-CoV-2 and improvement in clinical symptoms or in radiological assessment of disease related chest X-Ray.
The primary objective of the Phase I part is the safety, tolerability and efficacy of various CYNK-001 intravenous (IV) infusions in Covid-19 patients. CYNK-001 will be given in three doses over seven days to up to 14 subjects.
The Phase II part is a randomised, open-label, multi-site study designed to measure different CYNK-001 doses against a control group with a similar degree of infection and on best supportive care.
For the Phase II portion, the first co-primary endpoint is the virologic efficacy of CYNK-001 in enabling SARS-CoV-2 clearance from mucosal specimens and/or peripheral blood.
The second co-primary endpoint is the impact of the therapeutic on clinical symptoms in patients with Covid-19 related lower respiratory tract infection.
CYNK-001 was found to be well tolerated in patients with severe Covid-19 and on ventilator support who were treated as part of compassionate use programmes in the US.