Clinical Trials of Immune Tolerance for Protein/Gene-replacement Therapy
The ITN is currently inviting proposals for novel clinical trials with the aim of inducing tolerance in patients who receive gene/protein-replacement (e.g. hemophilia, Gaucher’s disease) or other exogenous protein therapy, in which the patients are at risk for developing an immune response to the biologic agent. The ideal proposal would have a testable mechanism of tolerance induction and a strategy for assays investigating this mechanism.
Clinical Trials in Immune Tolerance
The ITN accepts Concept Proposals year-round for novel clinical trials with testable hypotheses that are designed to induce immune tolerance in allergy and asthma, autoimmune disease, transplantation and type 1 diabetes. In addition, the ITN accepts proposals for the development of novel tolerance assays or mechanistic studies for the purposes of establishing new surrogate biomarkers of immune tolerance and investigating the mechanisms of clinical tolerance.
Information about the ITN’s approach to tolerance in each therapeutic area (allergy, autoimmune disease, type 1 diabetes and solid organ transplantation) can be found here.
Concept Proposal guidelines and templates can be found here.