Trials of Anti-PSMA Designer T Cells in Advanced Prostate Cancer (Phase 1). Revision

摘要

Anti-PSMA designer T cells Autologous T cells that are gene-modified to express chimeric immunoglobulin T cell receptors (TgTCR) that recognize the prostate specific membrane antigen. We will conduct Phase I dose-escalation trial with infusion of designer T cells into prostate cancer patients after non- myeloablative (NMA) conditioning. This procedure will allow for the stable engraftment and persistence of the infused cells for improved therapeutic effect. The first year efforts have been in preparation of a clinical-grade vector producer cell (VPC) line, production and testing of clinical vector supernatants and in harmonizing IRB-recommended protocol modifications and completing administrative features in advance of the trial. In year 2 the vector was received from NGVL after production delay. Patients will commence enrollment in year 3 January 2008.