U of M opens iPSC-derived CAR NK cell trial for patients with Non-Hodgkin Lymphoma as consolidation after an autologous transplant 

January 5, 2021

MINNEAPOLIS, MN - The University of Minnesota is pioneering a novel therapeutic approach to improve the curative potential of hematopoietic stem cell transplantation for patients with Non-Hodgkin Lymphoma that are at high risk of relapse. FT596, a natural killer (NK) cell engineered with a chimeric antigen receptor (CAR) that targets malignant B cells, is being administered to patients undergoing transplant to enhance the procedure and prevent cancer relapse. The Phase 1 clinical trial opened last month at the U of M, which is the first location in the world to bring this innovative therapeutic approach to patients.

This investigator-initiated clinical trial uses CAR NK cells derived from human induced pluripotent stem cells (iPSC) as a renewable cell source for product manufacture and off-the-shelf delivery to patients. The study’s Principal Investigator at the University of Minnesota is Veronika Bachanova, MD, PhD, Professor of Medicine at the Medical School and Lead of the Lymphoma Interdisciplinary Team at the U of M.

FT596 is engineered with three functional components that are intended to maximize the targeting and killing of malignant B cells. Specifically, FT596 directly targets the B-cell antigen CD19 and binds to the anti-cancer antibody rituximab that targets CD20, which provides FT596 with a unique dual mechanism of action in attacking tumor cells. Additionally, to promote NK cell survival after infusion, FT596 is also engineered with a third functional element to express IL-15, a critical modulator of immune response.

“FT596 is a pioneering NK cell therapy which has three genetic modifications 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. In an innovative design, we will infuse FT596 soon after autologous stem cell transplant to improve anti-cancer activity and survival in high-risk patients with non-Hodgkin lymphoma. I am thrilled to bring FT596 therapy to patients with relapsed B-cell lymphoma treated at the University of Minnesota and hope our approach will improve the cure rates.”

The multi-centered trial is investigating the safety and activity of the universal, off-the-shelf NK cell product, and builds 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. 

“This is part of our long-term strategy to transition from individual donor derived NK cell therapies to off-the-shelf engineered NK cell products that offer enhanced specificity, ease of administration, and access to more patients in the cancer community,” said Miller.

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

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 cancer.umn.edu.

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 www.med.umn.edu.