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Based on their data from 133 adult participants in one clinical trial, the researchers identified potential biomarkers associated with the development of the toxic effects, known as cytokine release syndrome and neurotoxicity. They also created algorithms aimed at identifying the rare patients whose symptoms were most likely to turn life-threatening.
The team's paper on neurotoxicity will be published online in Cancer Discovery at 12:05 a.m. Eastern Time Oct. 12. Their paper on cytokine release syndrome was published online in the journal Blood Sept. 18.
Researchers - Work - Basis - Algorithm - Doctors
The researchers anticipate that their work could be the basis for an algorithm that doctors could follow to reduce the risk of the severe side effects and occasional deaths, which have been seen in clinical trials of various CAR T-cell products. They said that their findings will need to be tested and improved upon by further study, and noted that their results arise from a clinical trial of a particular CAR T-cell product, which is made by and at Fred Hutch.
"It's essential that we understand the potential side effects of CAR T therapies" said Fred Hutch's Dr. Cameron Turtle, who led the research. "While use of these cell therapies is likely to dramatically increase because they've been so effective in patients with resistant or refractory B-cell malignancies, there is still much to learn."
CAR - T-cell - Product - US - Food
The first CAR T-cell product was recently approved by the U.S. Food and Drug Administration to treat certain leukemias. That product, like the one studied by the Fred Hutch team, reprograms patients' immune cells to kill blood cancer cells bearing a protein called CD19.
The 133 participants in the Fred Hutch clinical trial -- believed to be the largest sample size in any published study of CAR T-cell therapy side effects -- had advanced leukemias or lymphomas that had proven resistant to standard therapies. Over the last...
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