Single Patient Protocol: A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in a Patient With Metastatic Cancer Plus the Administration of Pembrolizumab

Overview

Single Patient Expanded Access

Background: Please refer to National Cancer Institute Surgery Branch (NCI-SB) protocol 18-C-0049, Amendment F. Objective: Under Individual Patient Expanded Access, to treat a patient with metastatic prostate cancer with autologous peripheral blood lymphocytes (PBL) that have been transduced with genes encoding T-cell receptors that recognize the mutated TP53 shared oncogene in the autologous cancer. Eligibility: * Must have measurable, metastatic disease as assessed per RECIST v1.1 criteria. * Must sign the informed consent document. * Willing to sign Durable Power of Attorney Form. * Must have all regulatory approvals prior to start of treatment. Design: * Please refer to NCI-SB protocol 18-C-0049, Amendment F. * The patient will be treated with a non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine, followed by the infusion of autologous transduced PBL and then high-dose aldesleukin. The patient will also receive pembrolizumab on Day -2 prior to cell administration and additional doses every 3 weeks following cell infusion until the time of disease progression.

Interventions

Eligibility