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U of M opens first-in-class engineered NK cell therapy trial for the treatment of patients with advanced multiple myeloma and leukemia

The University of Minnesota has become the first location in the world for a new innovative clinical trial for the treatment of acute myelogenous leukemia (AML) and multiple myeloma. The Phase 1 clinical trial for FT538 will eventually be a multicenter study but has initially opened exclusively at the M Health Fairview University of Minnesota Medical Center.

The clinical trial, sponsored by Fate Therapeutics, uses human induced pluripotent stem cells (iPSC) as a renewable cell source for manufacturing the universal, off-the-shelf, engineered natural killer (NK) cell therapy. The study’s Principal Investigator at the University of Minnesota is Murali Janakiram, MD, MS, Assistant Professor of Medicine at the U of M Medical School in the Division of Hematology, Oncology, and Transplantation.

FT538 is a cancer immunotherapy derived from a clonal master engineered iPSC line that incorporates three functional modifications that are intended to improve the outcomes for patients with AML and multiple myeloma. The first genetic modification is to delete the CD38 antigen on NK cells to allow the combination with anti-CD38 cancer antibodies like daratumumab to avoid killing of NK cells and also to enhance the metabolic fitness of the FT538 cells after they are infused.

It also contains a high-affinity, non-cleavable Fc receptor which has been modified to augment antibody-dependent cellular cytotoxicity. Lastly, to further promote NK cell survival after infusion, FT538 includes a third engineered element that expresses the NK cell growth factor IL-15.

“This is a unique clinical trial that is the scientific product of a deep understanding of our immune system and the biology of multiple myeloma and leukemia,” said Dr. Janakiram. “This cell therapy drug, if successful, will bring a new treatment option to our patients. As the principal investigator, I am excited to offer this clinical trial to our patients with multiple myeloma and leukemia who are in need of advanced, cutting-edge treatment.”

The clinical trial is born out of a multi-year partnership between the University of Minnesota and Fate Therapeutics. The FT538 Phase 1 trial is the sixth 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, engineered NK cell product, building off of the groundbreaking research done by Jeffrey Miller, MD, Deputy Director of the Masonic Cancer Center and Professor of Medicine at the University of Minnesota Medical School.

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