MINNEAPOLIS — A treatment for a form of leukemia that takes advantage of a person’s own natural killer cells is beginning clinical trials at the University of Minnesota Medical Center.
The drug therapy, called by the trademarked name TriKE, is designed to target acute myeloid leukemia, or AML, an aggressive form of the cancer that is diagnosed in about 21,000 people annually, according to the American Cancer Society.
About 10,000 people die of AML each year, said Dr. Erica Warlick, a Masonic Cancer Center researcher who is leading the trial. About half of patients treated for AML with chemotherapy relapse or require additional therapies, according to a Thursday news release from the University of Minnesota.
Recently developed drugs are likely to produce improvements, Warlick said in an interview. But TriKE — more or less an acronym for “tri-specific natural killer engagers” — could prove to be both more effective and less costly than existing therapies, she said.
That’s far down the road, Warlick cautioned. But for individuals who qualify and who are willing to accept the uncertainties of a trial it’s an opportunity to receive cutting-edge treatment — after years of testing in laboratories and then in animals.
“The first patient on this trial is going to be the first person to ever get it,” Warlick said. “And so it's come a long way. But it has a long way to go before it will be a routine treatment for patients.”
TriKE is a form of immunotherapy, what the National Cancer Institute calls the “fifth pillar” of cancer treatment after surgery, chemotherapy, radiation and drugs that target specific cancer cells. The form of immunotherapy that has come furthest is known as CAR-T cell therapies, with one already approved by the Food and Drug Administration for treatment of children with acute lymphoblastic leukemia and another for adults with advanced lymphomas.
But they’re really expensive.
Dr. Jeffrey Miller, who led the team at the Masonic Cancer Center that developed TriKE, explained in an interview that with CAR-T, the patient’s own T cells have to be extracted and then modified to attack the cancer.
“The cost of making a single dose of cells is anywhere from $350,000 to $500,000 that is billed to your insurance company,” he said. “The health care economic issues are mind-boggling.”
Miller’s team developed a protein molecule that can bind with anyone’s natural killer, or NK, cells — that really is a thing — so that they recognize specific targets. It doesn’t have to be customized to the individual patient but instead will be a drug that comes off the shelf and therefore will be “more economically responsible.”
His work has been focused on how to manipulate NK cells every since he came to the university in 1991, Miller said. His team has been working on this specific application for four or five years.
The trial is funded by GT Biopharma, a Southern California-based company.
Pharmaceutical companies — and their money — are brought in at this point in the process, Warlick said, because “funding clinical trials is incredibly expensive and typically beyond the capacity of an academic institution.”
Miller seconded that, adding that GT Biopharma has been a partner for a while.
“What we’ve learned is that to make our work sustainable you do have to start working with industry,” he said. “We had a novel idea. We were able to protect that idea, and that's what industry is really looking for.”
Is it for you?
If you’re an individual being treated for acute myeloid leukemia and you’re interested in learning more about the clinical trial for TriKE, Dr. Erica Warlick said the first step is to call the Masonic Cancer Center. Contact the cancer information nurse line at (612) 624-2620. You also can look at “find a clinical trial” in the patient section of their website at cancer.umn.edu/patients.