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Hum Gene Ther. 2018 May;29(5):559-568. doi: 10.1089/hum.2017.254. Epub 2018 Apr 5.

CAR T Cells in Trials: Recent Achievements and Challenges that Remain in the Production of Modified T Cells for Clinical Applications.

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1 Institute of Cellular Therapeutics , Hannover Medical School, Hannover, Germany.
2 Institute of Clinical Immunology, University Hospital Leipzig , Leipzig, Germany.
3 Fraunhofer Institute for Cell Therapy and Immunology , Leipzig, Germany.
4 Center for Molecular Medicine Cologne, University of Cologne , Cologne, Germany.
5 Department I for Internal Medicine, University Hospital Cologne , Cologne, Germany .


The adoptive transfer of chimeric antigen receptor (CAR)-modified T cells is attracting growing interest for the treatment of malignant diseases. Early trials with anti-CD19 CAR T cells have achieved spectacular remissions in B-cell leukemia and lymphoma, so far refractory, very recently resulting in the Food and Drug Administration approval of CD19 CAR T cells for therapy. With further applications and increasing numbers of patients, the reproducible manufacture of high-quality clinical-grade CAR T cells is becoming an ever greater challenge. New processing techniques, quality-control mechanisms, and logistic developments are required to meet both medical needs and regulatory restrictions. This paper summarizes the state-of-the-art in manufacturing CAR T cells and the current challenges that need to be overcome to implement this type of cell therapy in the treatment of a variety of malignant diseases and in a greater number of patients.


ATMP; CAR; T cell; cancer; cell production; immunotherapy

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