U of M Opens Three First-in-human Trials in One Month

A new cancer treatment therapy is being tested for the first time in patients at the M Health Fairview University of Minnesota Medical Center.

This trial is for patients with acute myeloid leukemia (AML) and B-cell lymphoma, and leverages groundbreaking research on stem cells and natural killer (NK) cells. The NK cell cancer immunotherapy, called FT516, is manufactured from a human induced pluripotent stem cell (iPSC) that has been genetically engineered to enhance its anti-tumor activity. In the US, it is the first-ever clinical trial of engineered iPSC-derived cell therapy for blood cancers.

The laboratories of Bruce Walcheck, PhD, Professor and Jimmy Wu, DVM, PhD, Associate Professor, both in the Department of Veterinary and Biomedical Sciences, generated the receptor that is expressed in the engineered NK cells.

“The enhanced receptor binds to antitumor therapeutic antibodies in a more stable manner,” said Walcheck. “In turn, the engineered NK cells more efficiently attach to antibody-coated tumor cells and kill them.”

“We potentially have an unlimited source of very similar, reproducible cancer fighters,” said Claudio Brunstein, MD, PhD, Professor of Medicine at the U of M Medical School, member of the Masonic Cancer Center, and lead researcher of this clinical trial. “This is opening a whole new door in cellular therapy.”

FT516 is the third first-in-human cancer treatment trial that has opened at the University of Minnesota in the last month.

A separate clinical trial, opened exclusively at the M Health Fairview University of Minnesota Medical Center, will evaluate GTB-3550 in patients with resistant or relapsing AML. GTB-3550 involves molecules referred to as a TriKE to activate the patient’s own NK cells to attack AML tumors.

“Building on over a decade of successful trials using NK cell infusions from related donors to kill tumors, this new TriKE™ molecule, with its modification to target AML, doesn’t need a related donor’s cells to work,” said lead researcher Erica Warlick, MD, Associate Professor of Medicine in the Division of Hematology, Oncology and Transplantation at the U of M Medical School. “The success of the Phase I trial could lead to the development of a broad pipeline of TriKE™ therapies that could be used against a variety of cancer targets.”

In addition, another clinical trial recently opened at the U of M and is a cell-based cancer immunotherapy for the treatment of advanced solid tumors. Run locally by Manish Patel, DO, Associate Professor of Medicine at the Medical School, the trial is testing the safety and activity of an NK cell product called FT500.

“If this trial is successful, it will provide a novel form of therapy that we will be able to pull off the shelf for patients with cancer and it will serve as a useful platform for making more effective treatments in the future,” said Patel.

Learn more about the latest trial, testing NK cell cancer immunotherapy FT516.