University of Minnesota expands clinical investigation of engineered iPSC-derived natural killer cells, opening U.S. clinical trial for the treatment of COVID-19

The first patient has received treatment in a new clinical trial that has opened at the University of Minnesota to test whether a novel cell therapy currently under clinical investigation as a treatment for acute myeloid leukemia (AML) and lymphoma can be effective as a treatment for COVID-19. The first-of-its-kind, engineered iPSC-derived natural killer (NK) cell product candidate, FT516, may play a role in diminishing viral replication of the novel coronavirus. NK cells have been known to play a role in protecting the body against viral infection; however, it is not known whether NK cells will be able to safely control COVID-19, the infectious disease caused by the virus SARS-CoV-2.

The clinical trial "Study of FT516 Safety and Feasibility for the Treatment of Coronavirus Disease 2019 (COVID-19) in Hospitalized Patients with Hypoxia," which is being supported by Fate Therapeutics, Inc., is being run locally by Joshua Rhein , M.D., Assistant Professor of Medicine in the University of Minnesota Medical School’s Division of Infectious Diseases and International Medicine.

"The medical research community has been mobilized to meet the unique challenges that COVID-19 presents," said Rhein. "There are limited treatment options for COVID-19, and we have been inundated daily with reports of varying quality describing the potential of numerous therapies. We know that NK cells play an important role in responding to SARS-CoV-2, the virus responsible for COVID-19, and that these cells often become depleted in infected patients. Our intent is to replenish NK cells in order to restore a functional immune system and directly target the virus."

Jeffrey Miller , M.D., Deputy Director of the Masonic Cancer Center, and Professor of Medicine in the Medical School’s Division of Hematology, Oncology and Transplantation, is a pioneer in the field of NK cells. As a collaborator on the trial, Dr. Miller will apply his decades of experience in NK cell biology and therapy in cancer to this international challenge.

One of the complexities of treating COVID-19 with cell therapy is the underlying inflammation that coincides with more severe cases of COVID-19 infection. The challenge is to carefully deliver off-the-shelf engineered NK cells at increasing doses to turn off viral replication without overly activating the immune system to make the lungs worse.

"The study has been carefully designed with appropriate medical checkpoints to investigate the potential of NK cells in a manner which we believe to be safe in COVID-19 patients," said Miller. "We will also track the immune response and duration of viral shedding to see if FT516 decreases shedding of COVID-19 in the respiratory tract. If successful, these off-the-shelf, iPSC-derived NK cells can be batch manufactured and sent nationwide to patients."

FT516 is manufactured from a master human induced pluripotent stem cell (iPSC) line that has been genetically engineered to enhance its binding to therapeutic antibodies. It was initially developed to attack AML and B-cell lymphoma, based on the groundbreaking research on stem cells and NK cells done at the Masonic Cancer Center.

FT516, which is being clinically developed by Fate Therapeutics for the treatment of advanced hematologic malignancies and solid tumors, was produced and manufactured at the U of M’s Molecular and Cellular Therapeutics (MCT) center, which offers full-service development and manufacturing of celland tissue-based products, monoclonal antibodies and other therapeutic proteins, as well as active pharmaceutical ingredients for use in Phase I, II or III clinical trials. M Health Fairview, the clinical partner of the Masonic Cancer Center, supports the MCT in the production of these molecules.


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