title: Biomarkers in T cell therapy clinical trials.
abstract: T cell therapy represents an emerging and promising modality for the treatment of both infectious disease and cancer. Data from recent clinical trials have highlighted the potential for this therapeutic modality to effect potent anti-tumor activity. Biomarkers, operationally defined as biological parameters measured from patients that provide information about treatment impact, play a central role in the development of novel therapeutic agents. In the absence of information about primary clinical endpoints, biomarkers can provide critical insights that allow investigators to guide the clinical development of the candidate product. In the context of cell therapy trials, the definition of biomarkers can be extended to include a description of parameters of the cell product that are important for product bioactivity. This review will focus on biomarker studies as they relate to T cell therapy trials, and more specifically: i. An overview and description of categories and classes of biomarkers that are specifically relevant to T cell therapy trials, and ii. Insights into future directions and challenges for the appropriate development of biomarkers to evaluate both product bioactivity and treatment efficacy of T cell therapy trials.
authors.affiliation: Department of Pathology and Laboratory Medicines, University of Pennsylvania Perelman School of Medicine, Abramson Family Cancer Research Institute, 422 Curie Boulevard, Stellar-Chance Laboratories, Philadelphia, PA 19104-4283, USA. Michael.kalos@uphs.upenn.edu
authors.forename: Michael
authors.initials: M
authors.lastname: Kalos
mesh_terms: D015415:Biomarkers / Q000378:metabolism*; D035843:Biomedical Research; D064987:Cell- and Tissue-Based Therapy; D002986:Clinical Trials as Topic; D006801:Humans; D013601:T-Lymphocytes / Q000166:cytology*
chemical_list: D015415:Biomarkers