Strategy Escalation: An Emerging Paradigm for Safe Clinical Development of T Cell Gene Therapies


Show simple item record Junghans, Richard Paul en_US 2012-01-09T20:58:38Z 2012-01-09T20:58:38Z 2010 en_US 2010-6-10 en_US
dc.identifier.citation Junghans, 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.issn 1479-5876 en_US
dc.description.abstract Gene 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.sponsorship FDA Office of Orphan Products Development; US Army Prostate Cancer Research Program; US Army Breast Cancer Research Program en_US
dc.language.iso en en_US
dc.publisher BioMed Central en_US
dc.rights Copyright 2010 Junghans; licensee BioMed Central Ltd. en_US
dc.rights.uri en_US
dc.title Strategy Escalation: An Emerging Paradigm for Safe Clinical Development of T Cell Gene Therapies en_US
dc.type article en_US
dc.identifier.doi 10.1186/1479-5876-8-55 en_US
dc.identifier.pubmedid 20537174 en_US
dc.identifier.pmcid 2904270 en_US

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