Collaborative Network for Clinical Research on Immune Tolerance (UM1)

The purpose of this FOA is to solicit applications for the Collaborative Network for Clinical Research on Immune Tolerance. The major goal of this Network is to develop new tolerogenic approaches for the treatment and prevention of disease in three clinical areas: asthma and allergic diseases; autoimmune diseases; and immune-mediated rejection of transplanted solid organs, tissues and cells. The scope of research to be carried out includes: 1) the design and conduct of clinical trials at all phases to evaluate the safety and efficacy of investigational products and approaches for the induction and maintenance of immune tolerance in humans; 2) the design and conduct of mechanistic studies and the development of tolerance assays as integral components of the clinical trials undertaken, including establishing and directing a consortium of laboratories; and 3) the provision of bioinformatics, data collection, validation and analysis resources. In addition, on a limited basis, the Network may support focused product development and nonclinical studies (e.g., toxicology, pharmacology, pharmacokinetics, etc.) essential for the subsequent evaluation of promising tolerance induction approaches in humans.