T-Cell Manufacturing for Protocol 18-H-0012

Background
The National Heart, Lung, and Blood Institute (NHLBI) is engaged in an investigational immunotherapy trial aimed at fighting kidney cancer cells. The Division of Intramural Research (DIR) sponsors a clinical protocol that modifies white blood cells from patients enrolled in the trial. The goal of this contract is to collect T-cells from these patients and ship them to the Contractor for manufacturing, ultimately developing the anti-tumor activity of the T-cell receptor.

Work Details
The Contractor shall perform the following tasks to modify the NHLBI-provided T-cells:

1. Isolation of the mononuclear layer;
2. T-cell activation in vitro;
3. CD4 depletion using magnetic beads;
4. Viral transduction with a retrovirus encoding the TCR for the HERV-E antigen;
5. Enrichment of transduced T-cells using CD34 beads;
6. Ex vivo expansion of transduced T-cells over a period of 14 days;
7. Analysis of the final T-cell product to ensure recognition of the target tumor antigen and compliance with purity and sterility criteria for release to NIH.

Period of Performance
The contract will require approximately 21 days to produce the modified T-cells once they are collected from patients.

Place of Performance
The work will be performed at Loyola University of Chicago.