Biomarkers in T cell therapy clinical trials
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REVIEW
Open Access
Biomarkers in T cell therapy clinical trials Michael Kalos
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. Review The central role for Biomarkers in clinical research
The ultimate objective for clinical trials is to evaluate the safety and efficacy of novel therapeutic agents. Although the ability to evaluate safety is in general rather straightforward, the ability to measure clinical efficacy is often compromised. The reasons for this are multiple and include the variable and often long times to progression, the fact that direct measurements on target tumors are often not possible, and also include patient- intrinsic effects related to both patient and tumor heterogeneity. Nonetheless, early evidence for product efficacy and bioactivity is of critical importance in the clinical trial process to guide the further development of the candidate product. Well-designed biomarker studies provide a primary mechanism to evaluate product efficacy and bioactivity, and also provide fundamental insights into mechanistic aspects of the treatment regimen. The clinical development path for novel therapeutics has historically followed a rather rigid and iterative approach that has imposed certain significant limitations Correspondence: [email protected] 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
on the effective development of promising therapeutics, since the inherent rigidity of the approach does not allow for the flexibility to either accelerate trials when early results are particularly promising, or to modify the trial design as information and knowledge about the treatment impact, response and biomarker profile is gene
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