Loyola University Chicago and Loyola Medicine have announced plans to become the first Chicago center to produce cancer-fighting CAR-T cells to treat leukemia and lymphoma.
CAR-T cell therapy has been shown to be remarkably effective in treating cancer patients who have failed standard treatments, but it is expensive and can cause severe side effects. Loyola is planning on producing a more purified CAR-T cell product that potentially could reduce toxicities and costs.
The Leukemia Research Foundation is supporting the research with a lead gift of $250,000 to Loyola University Chicago.
CAR-T therapy harnesses the patient's immune system to fight cancer. In the Loyola clinical trial, T-cells will be collected from the patient and sent to Loyola's clean lab. There, the cells will be genetically modified to target and kill cancer cells. Millions of these engineered T-cells then will be infused back into the patient. (T-cells play an essential role in the immune system. They flow through the bloodstream to fight viruses, bacteria and other foreign invaders. CAR-T is short for chimeric antigen receptor T-cell.)
Loyola is among the Chicago centers that have treated patients with CAR-T cells developed by pharmaceutical companies. Now Loyola will be the first Chicago center to produce its own CAR-T cells. The cells will be made available to other centers in Chicago and beyond once initial testing is completed.
"We're working to develop a more pure CAR-T product that would lessen toxic side effects and potentially increase the number of eligible patients," said Patrick Stiff, MD, Loyola's director of hematology/oncology research and division director of hematology/oncology. Dr. Stiff is directing Loyola's CAR-T research, along with Michael Nishimura, PhD, program director of immunologic therapies.
Kevin Radelet, executive director of the Leukemia Research Foundation, said supporting CAR-T research "directly aligns with our mission of funding medical research and enriching the quality of life of those touched by these diseases."
The Leukemia Research Foundation, based in Northfield, Illinois, has awarded $30 million in research grants to more than 500 researchers and more than 200 research institutions in 13 countries. The Foundation also is providing $1.67 million in "New Investigator" grants to 12 young researchers during the 2018-2019 fiscal year. Loyola University Medical Center participated in a groundbreaking clinical trial of CAR-T therapy published in the New England Journal of Medicine. The multi-center study included patients with certain types of large B cell lymphoma who had failed standard treatments. Forty-two percent were in complete remission after 15 months - a remarkable result since most patients had exhausted all other treatment options.
The study found that 95 percent of the patients experienced at least one severe side effect. By producing a less toxic product, it may be possible to move the expensive inpatient therapy to an outpatient setting. This could allow many more patients to be treated, including Medicare patients who comprise approximately 50 percent of the lymphoma population.
The CAR-T cells will be produced in the McCormick Tribune Foundation Center for Cellular Therapy in Loyola's Cardinal Bernardin Cancer Center. The center provides a super-clean environment to produce pure cell populations free of contamination from fungi, microbes, etc.
Loyola's cellular center complies with strict standards set by the Food and Drug Administration and National Institutes of Health. Loyola has used the cellular center to produce cancer-fighting immune cells for clinical trials in melanoma and ovarian cancer patients, and other trials are planned. Also, Dr. Nishimura is producing immune cells for an NIH clinical trial on an experimental treatment for kidney cancer.
Loyola initially will test its CAR-T cells on patients with acute lymphocytic leukemia and B-cell non-Hodgkin's' lymphoma who have failed standard treatments. A Phase 1 trial will determine the effectiveness and toxicity of the CAR-T cells. Then, a Phase 2 trial will determine the effectiveness of the CAR-T cells in a larger patient sample, consisting of patients from throughout the Chicago area. Loyola will offer CAR-T cells to other medical centers in this region, across the country and even globally to advance the science more quickly.
The Leukemia Research Foundation's support of Loyola's CAR-T research arose out of a casual conversation Dr. Stiff had with foundation officials about Loyola's CAR-T research. "We realized there were synergies between our goals and the foundation's goals," Dr. Stiff said.
Mr. Radelet added, "We are thrilled to be able to support this groundbreaking research in Chicago, where the Leukemia Research Foundation has a large footprint."