Background & Purpose

Please click on the “RFA ANNOUNCEMENT” link in the upper right corner for complete information.

PURPOSE

JDRF is soliciting projects to validate high priority candidate T cell biomarkers for T1D and to transition associated assays to fit-for-purpose status. The purpose of this RFA is to encourage the T1D biomarker community to transition widely referenced T1D relevant T cell biomarkers and assays towards validation and standardization for uniform use across the research community.

BACKGROUND

The mission of the JDRF Immunotherapies program is to establish effective immune therapies to slow down, halt, and reverse the T1D disease process. Biomarkers have the potential to play a vital role as catalysts for the clinical testing of immune therapies for T1D, by enabling the design of more effective clinical trials on the path to their approval.

In type 1 diabetes (T1D), T cells play a key role in the destruction of insulin-producing beta cells. As such, they have been widely studied, both to better understand the disease and to evaluate responses to immune therapies in subjects with or at risk of T1D. The T cell biomarker community has actively pursued two categories of T cell biomarkers; antigen-specific and non-antigen-specific. In numerous studies, T cell biomarkers have allowed the unequivocal association of T cell activity with the T1D disease process and in recent efforts, intriguing associations between patterns of T cell changes and response to immune therapies have been emerging.

Despite recent advances, a comprehensive set of easily and reliably measurable T cell biomarkers are not available. Rapidly emerging technologies, including multi-omics approaches, are increasingly being utilized to evaluate T cells and add to the need to establish harmonized SOPs for T cell measurements. Large sample volumes and sample sets are particularly needed for projects that involve replicate and reproducibility testing, or assay optimization.