Masonic Cancer Center U of M

U of M opens first in class triple gene edited NK cell trial for treatment of patients with advanced B cell lymphoma

The University of Minnesota has pioneered the development of promising cell-based cancer immunotherapy called FT596, and today announced opening Phase 1 clinical trial using FT596 for treatment of Relapsed/refractory B cell lymphoma and chronic lymphocytic leukemia. The U of M is the first location in the world to open this innovative treatment.  

The clinical trial, sponsored by Fate Therapeutics, uses human-induced pluripotent stem cells (iPSC) as a renewable cell source for manufacturing the NK cell therapy. The study’s Principal Investigator at the University of Minnesota is Veronika Bachanova, MD, PhD, Associate Professor of Medicine at the Medical School and Lead of the Lymphoma Interdisciplinary Team at the U of M.

FT596 is a triple gene-edited product to maximize dual targeting mechanisms to B cell malignancies. Specifically, it targets the B cell antigen CD19 through a chimeric antigen receptor (CAR) and also contains a high affinity, non-cleavable Fc receptor to bind to the anti-cancer antibody rituximab that targets a second B cell antigen, CD20. Lastly, to promote their own survival after infusion, the FT596 cells have been designed with a third engineered element to express the membrane-bound NK cell growth factor IL-15.

“FT596 is a pioneering NK-based cell therapy which has a triple genetic modification to improve cancer cell recognition and killing,” said Bachanova. “In addition, the advantage of FT596 compared to existing cell therapies is its ‘off the shelf’ availability and innovative design, which promises to improve persistence and anti-cancer activity in patients. I am thrilled to finally bring FT596 therapy to the clinic and offer this promising therapy to patients with refractory B-cell lymphoma/leukemia treated at the University of Minnesota.”

The clinical trial is born out of a multi-year partnership between the University of Minnesota and Fate Therapeutics. The FT596 Phase 1 trial is the fifth clinical trial to emerge from the collaboration between the U of M and Fate.

The multicentered trial is investigating the safety and activity of a universal, off-the-shelf natural killer (NK) cell product, building off of the groundbreaking NK research done by Jeffrey Miller, MD, Deputy Director of the Masonic Cancer Center and Professor of Medicine at the University of Minnesota Medical School.

FT596 was produced and manufactured at the University of Minnesota’s Molecular and Cellular Therapeutics (MCT) center, which offers full-service development and manufacturing of cell- and 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.

About the Masonic Cancer Center, University of Minnesota

The Masonic Cancer Center, University of Minnesota, is the Twin Cities’ only Comprehensive Cancer Center, designated ‘Outstanding’ by the National Cancer Institute. As Minnesota’s Cancer Center, we have served the entire state for more than 25 years. Our researchers, educators, and care providers have worked to discover the causes, prevention, detection, and treatment of cancer and cancer-related diseases. Learn more at

About the University of Minnesota Medical School

The University of Minnesota Medical School is at the forefront of learning and discovery, transforming medical care and educating the next generation of physicians. Our graduates and faculty produce high-impact biomedical research and advance the practice of medicine. Learn how the University of Minnesota is innovating all aspects of medicine by visiting