Characterizing CAR T Cell Therapy Biomarkers Through Multianalyte Analysis

Identification and monitoring of biomarkers related to T cell activation and associated cytokine release syndrome (CRS) will be necessary to fully realize the immense potential of chimeric antigen receptor (CAR) T cell therapy. Such biomarkers could be used to guide clinical development of candidate therapies1, provide mechanistic insight into patterns of resistance², and evaluate strategies to mitigate toxicity³. Establishment of predictive biomarkers is critical to maximizing therapeutic benefits of immunotherapy⁴. Correlating biomarkers with clinical evidence will facilitate early identification of patients at risk of developing CRS and enhance efforts to safely deliver CAR T therapy⁵.

The successful identification of biomarkers to achieve these goals will require assays that meet several criteria. The assay must be able to simultaneously measure a broad panel of analytes with a high degree of accuracy within a brief timeframe1,6, and provide rapid and efficient evaluation of patient response³.

The Ella immunoassay platform with Simple Plex™ multianalyte assays enable fast and accurate quantitation of analytes of interest and allow for the detailed analysis of an individual’s response to T cell infusion. A large catalog of validated assays, and a small required sample size (25 μL) make this hands-free assay well-suited for characterizing dynamic molecular response. In order to assess the utility of Ella in this context, we analyzed samples from three CAR T infused donors (10 time points each collected over 13 days, including pre and post- treatment for each donor).