Request for Proposals: Clinical Trials of Immune Tolerance in Transplantation Using Deceased-Donor Organs

The Immune Tolerance Network (ITN) is currently seeking proposals for clinical tolerance trials in transplantation using solid organs or islets from deceased donors.

Proposals should meet the following criteria:

1. There is strong support with preclinical data and/or evidence from clinical pilot studies; if preclinical studies alone are used to support the proposal, these studies should include brain dead donors or discuss why such studies are not needed with the proposed protocol.
2. The donor and recipient are HLA mismatched.
3. Biomarker use and/or discovery should be incorporated into the immunosuppression withdrawal plan.

The ideal proposal would have a testable mechanism of tolerance induction and a strategy for assays investigating this mechanism. The ITN is particularly interested in proposals for phase II trials (with approximately 5-30 patients). Proposals are welcome from academic, government and industry-based investigators. Funding will vary based on the type and scope of the trial.

The application process will be in two stages:

• Potential applicants must submit a one-page Letter of Inquiry that is due no later than August 29, 2014.

• Based on evaluation of the Letter of Inquiry, the ITN will then invite more detailed formal applications in early September 2014. Invited Concept Proposals will be due in early October 2014.

Please direct all proposal submissions and any questions concerning this RFP to:

Philip Bernstein, PhDExecutive Director of Strategic Review and PlanningPhone: (240) 235-6132Email: pbernstein@immunetolerance.org‍

Additional information and instructions: RFP – Transplantation Using Deceased-Donor Organs

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