UR Medicine’s Wilmot Cancer Institute is part of a national clinical trial for an innovative new therapy that involves engineering a patient’s own immune cells to attack cancer, in this case lymphoma.
Called CAR T-cell therapy, the approach is touted as one of the most powerful cancer treatments to emerge from research laboratories in years.
Ed Foster, 64, of Elmira, who has diffuse large B-cell lymphoma, is the first person in upstate New York to receive the therapy at Wilmot. His treatment begins this week and he’ll remain hospitalized for several days in anticipation of serious side effects, some of which can be life-threatening.
CAR T-cell therapy, sometimes known as a “living drug,” is being tested in patients who have few options left but who are otherwise healthy enough to be eligible for the clinical study. Investigators estimate that 40 percent of the individuals who volunteer to undergo the experimental treatment will respond and achieve remission.
Oncologists diagnosed Foster a year ago with a type of non-Hodgkin lymphoma, a common blood cancer that afflicts about 72,000 people annually. He went through two courses of standard chemotherapies for diffuse large B-cell disease, but the treatment failed because his cancer cells proved to be resistant.
“I’m surrendering myself to the process, and I feel great,” said Foster, the married father of three children, and an avid hunter and outdoorsman who also practices medicine as an internist in Elmira.
“I’m very optimistic despite there being some unknowns about this treatment,” he said. “I have not lost a second of sleep over the therapy because, what’s the alternative? The real miracle is that I’m being cared for by the right people, at the right institution, and getting the best therapy possible. I feel like I’m going to the Super Bowl.”
Foster said he first learned about the possibilities of immunotherapy as a medical student. Over the years he’s found himself telling his own patients with cancer to “visualize your body fighting the disease” because it made sense. All the while, he knew that researchers were working toward developing actual drugs and other interventions based on this same approach.
“Now, it’s no longer theoretical,” Foster said. “The fantasy is reality—and it has great promise.”
Around the time that Foster’s initial treatments failed, Wilmot was selected to participate in the immunotherapy study. It is sponsored by Kite Pharma Inc., a California company that has been working with the National Cancer Institute to develop the process and technology to manipulate patients’ immune cells and produce a viable immunotherapy. Wilmot is among 16 institutions originally selected to participate in the phase II trial; Foster has been the only Wilmot patient eligible so far.
The study is unusual due to intense scrutiny over every single case. Most multi-center clinical trials allow each institution to enroll patients and proceed with some independence. But for this study, the first person to receive the engineered immune cells at each of the medical sites will be watched exclusively until they are healthy enough to be discharged from the hospital. No one else will receive the treatment during that time. At the end of the trial later this year, if the data meets the study’s objectives, the new immunotherapy could qualify for Food and Drug Administration review and approval.
Jonathan W. Friedberg, M.D., M.M.Sc., director of the Wilmot Cancer Institute who holds the Samuel E. Durand Chair in Medicine, and Patrick M. Reagan, M.D., a senior instructor, are leading the study at Wilmot.
“It’s an immense privilege and endorsement of our program that we were asked to be part of this study,” Friedberg said.
He and Reagan assembled a team of physicians and nurses from across the University of Rochester Medical Center to receive special training to participate. Only Friedberg, Reagan, and the trained group will take part in Foster’s care.
“This clinical trial is the first real big test,” said Friedberg, a national educator and well-published expert on lymphoma. “The reports from the scientific literature from smaller studies tell us that by successfully engineering a patient’s immune cells, you can destroy cancer cells—and that’s very exciting. It’s no longer just science fiction.”
Added Reagan: “There is a chance this is going to help in a profound way. What’s interesting about the immune system is that sometimes cancers can hide and not be recognized as foreign. CAR T-cell therapy bypasses that problem and directs the immune cells against the tumor specifically.”
In fact, scientists are discovering many different ways in which the immune system can fight cancer. Immunotherapy can be delivered through vaccines, drugs, or adoptive cell therapy, which is the route Foster is taking.
CAR (chimeric antigen receptor) T-cell therapy begins with a procedure called pheresis, in which some of Foster’s blood was removed and filtered. T cells from his immune system (a type of white blood cell) were separated out and immediately flown to Kite Pharma. At Kite’s facility, scientists genetically modified Foster’s T cells using DNA from a dead HIV virus (the virus that causes AIDS)—resulting in their ability to hunt and kill the lymphoma. The modified cells are then infused back into Foster’s body intravenously.
For the first few weeks, Foster’s immune system will go into overdrive and he will be sick, Reagan explained. Up to 15 doctors and nurses will be involved in managing the treatment’s side effects, while at the same time allowing Foster’s newly charged immune system to fight the cancer.
“It’s really important to have an honest and frank discussion with the patient about this process, step-by-step, all possible outcomes, and the reason you think a clinical trial is the best route,” Reagan said. One person who participated in the same CAR T-cell study at another site has died; data on the total number of trial participants so far in the U.S., or the cause of death, was not available.
Plenty of times, Foster said, he’s had to have those same difficult conversations with his own patients—people who are friends and neighbors from his small town in the Southern Tier. When Foster became a patient, however, he decided to set aside the doctoring mindset. But it hasn’t been easy.
“There’s been a little bit of denial, a little bit of hope, and some detachment,” he said. “But I’ve come to the realization that I have a lot of people rooting for me.”
“It’s important,” he added, “to make people aware that right here in our backyard there’s cutting-edge research that’s not just in the lab but is offering people like me a second chance.”
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