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    Definition and application of good manufacturing process-compliant production of CEA-specific chimeric antigen receptor expressing T-cells for phase I/II clinical trial.

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    Authors
    Guest, R
    Kirillova, N
    Mowbray, S
    Gornall, Hannah
    Rothwell, Dominic G
    Cheadle, Eleanor J
    Austin, E
    Smith, K
    Watt, S
    Kühlcke, K
    Westwood, N
    Thistlethwaite, Fiona C
    Hawkins, Robert E
    Gilham, David E
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    Affiliation
    Cellular Therapeutics, Grafton Street, Manchester
    Issue Date
    2014-02
    
    Metadata
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    Abstract
    Adoptive cell therapy employing gene-modified T-cells expressing chimeric antigen receptors (CARs) has shown promising preclinical activity in a range of model systems and is now being tested in the clinical setting. The manufacture of CAR T-cells requires compliance with national and European regulations for the production of medicinal products. We established such a compliant process to produce T-cells armed with a first-generation CAR specific for carcinoembryonic antigen (CEA). CAR T-cells were successfully generated for 14 patients with advanced CEA(+) malignancy. Of note, in the majority of patients, the defined procedure generated predominantly CD4(+) CAR T-cells with the general T-cell population bearing an effector-memory phenotype and high in vitro effector function. Thus, improving the process to generate less-differentiated T-cells would be more desirable in the future for effective adoptive gene-modified T-cell therapy. However, these results confirm that CAR T-cells can be generated in a manner compliant with regulations governing medicinal products in the European Union.
    Citation
    Definition and application of good manufacturing process-compliant production of CEA-specific chimeric antigen receptor expressing T-cells for phase I/II clinical trial. 2014, 63 (2):133-45 Cancer Immunol Immunother
    Journal
    Cancer Immunology, Immunotherapy
    URI
    http://hdl.handle.net/10541/315938
    DOI
    10.1007/s00262-013-1492-9
    PubMed ID
    24190544
    Type
    Article
    Language
    en
    ISSN
    1432-0851
    ae974a485f413a2113503eed53cd6c53
    10.1007/s00262-013-1492-9
    Scopus Count
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