Immunotherapy Using Chimeric Antigen Receptor-Engineered T Cells: A Novel Cellular Therapy with Important Implications for the Clinical Laboratory

Abstract BACKGROUND We have entered a new era of cancer therapy, with a number of immune-based therapies already used clinically as a standard of care. Adoptive cellular immunotherapy using T cells genetically modified with chimeric antigen receptors (CAR-T cells) represents a novel therapeutic approach. CAR-T cells have produced clinical responses in B-cell malignancies that are otherwise refractory to conventional therapies. Two CAR-T cell therapies obtained regulatory approval in 2017, with many more of these therapies under clinical development. CONTENT This review focuses on the current state of adoptive cellular immunotherapy, specifically CAR-T cells, in the clinic and how this therapy differs from traditional small molecule and biologic therapies. Areas in which the clinical laboratory is affected by these novel therapies are discussed. Opportunities for the clinical laboratory to help guide these therapies are also highlighted. SUMMARY The clinical laboratory will play an integral role in the care of patients undergoing adoptive cellular therapy with engineered T cells. There are many ways that this new therapeutic approach affects the clinical laboratory, and the clinical laboratory will likely play a critical role in managing patients that are treated with CAR-T cell therapy.