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Customized CAR-T treatments for leukemias and lymphomas have offered new hope to patients with a difficult-to-treat disease, but artificial cell therapies may cause a dangerous immune response called cytokine release syndrome (CRS) . Researchers led by the Norris Comprehensive Cancer Center at the University of Southern California have developed a new type of T-CARD to eliminate this adverse effect. They have been proven by a small study done on the human being that they were on the right track.
The CAR-T cell therapy tested at the USC has not caused any serious side effects in 25 lymphoma patients who have received it, announced today at the university. Six of the patients went into complete remission. The study was published in the journal Nature Medicine, and researchers are planning a phase 2 study on a larger group of patients, according to a statement.
SRC occurs when immune cells release a flow of substances into the bloodstream that causes symptoms such as fever, rash, breathing problems, and swelling of the brain. Because side effects can be life-threatening, many TEN-CAR recipients must be treated in hospital.
RELATED: Stem cells fight the release of CAR-T cytokines in mice
Since the FDA approved two CAR-T treatments in 2017, Kymriah from Novartis and Yescarta from Gilead, oncology researchers are experimenting with different methods to make the technology safer. Last year, Melbourne-based Cynata Therapeutics announced that it has developed mesenchymal stem cells that can contain CRS reactions. Scientists at the Fred Hutchinson Cancer Research Center have identified biomarkers that can predict CRS and are experimenting with different varieties and doses of CAR-T cells.
USC's research was aimed at finding a safer CAR (chimeric antigen receptor) molecule than that used in the two FDA-approved CAR-T therapies, both of which kill CD19-bearing cancer cells. They landed on a variant of the CAR called CD19-BBz (86), they explained in the study.
When T cells were transduced with CD19-BBz (86) in the laboratory, they produced lower levels of cytokines, while maintaining their ability to kill CD19 tumor cells, the USC-led team reported. CD19-BBz CAR-T cells (86) did not cause CRS in mice.
The researchers then tested the cells at three different doses during the clinical trial. The six patients who achieved remission received the highest dose and five of them were still free of disease more than six months after receiving the CAR-T cells. Two additional patients in this branch of the trial presented partial remissions. Some of the study participants reported mild side effects, but no need for treatment, according to the authors.
"Toxicities are currently the biggest barrier to using CAR-T therapy," said lead author Si-Yi Chen, MD, Ph.D., a professor at the USC's Keck School of Medicine. "I hope this safer version of CAR T-Cell Therapy could one day be administered to outpatients. "
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