Strategies for Comprehensive Immune Monitoring of Clinical Trials to Advance Human Immunotherapy in Remote Settings

Abstract

Abstract Comprehensive immune monitoring of clinical trials relies on the ability to generate high-quality data to gain insights into disease detection and treatment. Execution of longitudinal clinical trials in flow cytometry is complex due to logistical challenges in high-quality sample collection. Our group has developed a novel blood “immune signature” of cancer nonresponsiveness that predicts failure to make a clinical response to checkpoint immunotherapies targeting the PD-1/PD-L1 pathway. Recent advances in CyTOF™ technology allow us to expand clinical implementation to remote settings with a 50-plus-marker panel. CyTOF is the only technology that allows remote asynchronous sample collection with the largest immunophenotyping panel yielding reproducible results. This approach is uniquely enabled using a stable lyophilized large-scale staining panel and achieving comprehensive marker coverage in one panel minimizes blood sample required. CyTOF enables a simplified workflow including blood collection and processing in remote locations to enable the simplest clinical trial infrastructure complexity and cost, easily implemented in current hospital labs. This study is designed to demonstrate the clinical impact and utility of CyTOF for a highly simplified workflow for multi-site clinical trials. We report on the first phase of this project that implements this simplified workflow across remote clinical collection sites, data integration, and analysis.