By The National Cancer Institute

In November 2023, the Food and Drug Administration announced that it was investigating more than 20 instances of second cancers—specifically, T-cell lymphomas—in people who had been treated with CAR T-cell therapies. In several instances, the agency noted, genes used to make the CAR T-cell treatments were present in the secondary T-cell lymphomas, raising the possibility that the engineered T cells had caused the cancers.

On June 4, 2024, one of the largest studies of second cancers following CAR T-cell therapy and a case report on an individual who developed a T-cell lymphoma following CAR T-cell therapy were simultaneously published in the New England Journal of Medicine (NEJM).

In this Q&A, Stephanie Goff, M.D., of NCI’s Center for Cancer Research, who specializes in developing and testing gene-engineered T-cell therapies, including CARs, talks about these two recent additions to what’s known about CAR T-cell therapy and second cancers and what this issue means in general for patients and this area of research.

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