New lymphoma T-cell therapy, made in less than a day, shows promising results with fewer side effects
Each of the patients was at a crossroads. Conventional chemotherapy for their lymphomas had failed-one, twice, half-a-dozen times.
Now, each had a choice: They could take a U.S. Food and Drug Administration (FDA)-approved immunotherapy drug that's effective about half of the time but also comes with serious risks. Or they could volunteer to be among the first to try an experimental drug developed by Case Comprehensive Cancer Center pathologist David Wald (GRS '03, pathology; MED '05). Researchers suspected the drug, called UF-Kure19, might have fewer side effects, and they hoped that maybe, possibly, it could shift those 50-50 odds in the patients' favor.
Today, nearly two years after the first patient received UF-Kure19, 14 more have taken a chance on the new drug in Cleveland and Iowa City, Iowa. In results available so far, 13 patients went into complete remission while still exhibiting far fewer side effects than they might have had with similar drugs.
UF-Kure19 is part of a family of treatments called CAR-T cell therapies. These drugs transform patients' own immune cells into cancer killers. But unlike other CAR-T drugs, which take up to two weeks to produce, UF-Kure19 is made in less than a day, thanks to an innovative ultrafast manufacturing process pioneered by Wald, the John D. Crissman and Francis D. Drake Professor in Pathology at Case Western Reserve's School of Medicine and co-leader of the cancer center's Immune Oncology Program.
"CAR-T cell therapy is essentially a living drug," said Wald, also a pathologist with University Hospitals (UH). Typically, CAR-T cell therapy starts with drawing some of the patient's blood and separating out T cells, which are immune cells that can learn to identify and kill pathogens. Once isolated, the patient's T cells are genetically modified to spot and kill cancer cells, then grown in culture for a few weeks. Thus armed, they are then infused back into the patient's bloodstream, where they multiply and start attacking cancer.
More than 30,000 people, mostly patients with blood cancers for whom other therapies have failed, have been treated with CAR-T cell drugs since the first such drug was approved by the FDA in 2017. Some are cured. But the drugs don't work for everyone.