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dc.contributor.authorJunghans, Richard Paulen_US
dc.date.accessioned2012-01-09T20:58:38Z
dc.date.available2012-01-09T20:58:38Z
dc.date.copyright2010en_US
dc.date.issued2010-6-10en_US
dc.identifier.citationJunghans, Richard Paul,. "Strategy Escalation: An emerging paradigm for safe clinical development of T cell gene therapies" Journal of Translational Medicine 8:55. (2010)en_US
dc.identifier.issn1479-5876en_US
dc.identifier.urihttp://hdl.handle.net/2144/2941
dc.description.abstractGene therapy techniques are being applied to modify T cells with chimeric antigen receptors (CARs) for therapeutic ends. The versatility of this platform has spawned multiple options for their application with new permutations in strategies continually being invented, a testimony to the creative energies of many investigators. The field is rapidly expanding with immense potential for impact against diverse cancers. But this rapid expansion, like the Big Bang, comes with a somewhat chaotic evolution of its therapeutic universe that can also be dangerous, as seen by recently publicized deaths. Time-honored methods for new drug testing embodied in Dose Escalation that were suitable for traditional inert agents are now inadequate for these novel "living drugs". In the following, I propose an approach to escalating risk for patient exposures with these new immuno-gene therapy agents, termed Strategy Escalation, that accounts for the molecular and biological features of the modified cells and the methods of their administration. This proposal is offered not as a prescriptive but as a discussion framework that investigators may wish to consider in configuring their intended clinical applications.en_US
dc.description.sponsorshipFDA Office of Orphan Products Development; US Army Prostate Cancer Research Program; US Army Breast Cancer Research Programen_US
dc.language.isoenen_US
dc.publisherBioMed Centralen_US
dc.rightsCopyright 2010 Junghans; licensee BioMed Central Ltd.en_US
dc.rights.urihttp://creativecommons.org/licenses/by/2.0en_US
dc.titleStrategy Escalation: An Emerging Paradigm for Safe Clinical Development of T Cell Gene Therapiesen_US
dc.typearticleen_US
dc.identifier.doi10.1186/1479-5876-8-55en_US
dc.identifier.pubmedid20537174en_US
dc.identifier.pmcid2904270en_US


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Copyright 2010 Junghans; licensee BioMed Central Ltd.
Except where otherwise noted, this item's license is described as Copyright 2010 Junghans; licensee BioMed Central Ltd.