Currently IFNg ELISpot assays are the primary analytical method employed for the assessment of anti-CAR-T cellular immunogenicity in CAR-T clinical trials. These assays require large volumes of blood to be drawn from patients, multiple steps to process the blood which introduce variability into the assay and are minimally informative. This presentation will discuss adapting an ex-vivo whole blood assay which has been utilized in multiple clinical trials, to assess cellular immunity toward novel CAR-T antigens. Benefits of the closed system ex-vivo whole blood assay include, but are not limited to, reduced intrinsic assay variability and blood volume requirements while providing additional information on the immune response compared to ELISpot Assay. Key parameters in assay development for a novel antigen will be discussed such as assay standardization as well as choice of optimal controls.
Learning Objectives:
Upon completion, participants will be able to identify and describe current issues with clinical anti-CAR-T cellular immunogenicity assays.
Upon completion, participants will be able to understand the benefits of a closed system ex-vivo whole blood culture to assess cellular immunogenicity
Upon completion, participants will be able to understand current challenges in developing anti-CAR-T cellular immunogenicity bioanalytical methods.
