How to find a needle in an immunological haystack

Approximately 1 in 200 people world-wide are diagnosed with RA, a chronic autoimmune disease that can result in permanent disability. RA patients often also suffer from other complaints, such as chronic fatigue and depression, which severely impact quality of life as well as the ability to work. As such, the personal, societal and economic costs of RA are substantial. Novel treatments are needed that can retrain the immune system and cure autoimmune disease.  

Clinical trials of such treatments as well as their future application into clinical practice requires tools to measure whether the intended effect on the immune system is achieved. In this project we aimed to develop such tools. We used blood samples from healthy donors and RA patients to develop sensitive response assays for targets that are relevant for our clinical trial. We completed the development of two assays which can be used to study the number and function of cells that respond to our treatment. These assays were optimized to connect well to the amount of available blood in our clinical trial. A third assay to determine the antigen-specific receptor is still in development.  

We will validate the developedse assays by applying them to samples from patients before, during, and after treatment with our cell therapy. The results of these validation studies will confirm the applicability of the assays in support of further clinical development, and provide indication whether they can be used as response predictors to assess treatment eligibility.