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KMID : 0043320160390040437
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Archives of Pharmacal Research
2016 Volume.39 No. 4 p.437 ~ p.452
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Current status and regulatory perspective of chimeric antigen receptor-modified T cell therapeutics
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Kim Mi-Gyeong
Kim Dong-Yoon
Suh Soo-Kyung
Park Ze-Won
Choi Min-Joung
Oh Yu-Kyoung
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Abstract
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Chimeric antigen receptor-modified T cells (CAR-T) have emerged as a new modality for cancer immunotherapy due to their potent efficacy against terminal cancers. CAR-Ts are reported to exert higher efficacy than monoclonal antibodies and antibody?drug conjugates, and act via mechanisms distinct from T cell receptor-engineered T cells. These cells are constructed by transducing genes encoding fusion proteins of cancer antigen-recognizing single-chain Fv linked to intracellular signaling domains of T cell receptors. CAR-Ts are classified as first-, second- and third-generation, depending on the intracellular signaling domain number of T cell receptors. This review covers the current status of CAR-T research, including basic proof-of-concept investigations at the cell and animal levels. Currently ongoing clinical trials of CAR-T worldwide are additionally discussed. Owing to the lack of existing approved products, several unresolved concerns remain with regard to safety, efficacy and manufacturing of CAR-T, as well as quality control issues. In particular, the cytokine release syndrome is the major side-effect impeding the successful development of CAR-T in clinical trials. Here, we have addressed the challenges and regulatory perspectives of CAR-T therapy.
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KEYWORD
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Chimeric antigen receptor-modified T cells, Clinical trials, Manufacture, Safety, Efficacy, Regulatory perspective
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