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

2019-10-28 13:57:20 | BioPortfolio


Single Patient Expanded Access



Please refer to National Cancer Institute Surgery Branch (NCI-SB) protocol 18-C-0049, Amendment F.


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.


- 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.


- 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.

Study Design



Individual Patient TCR Transduced PBL, Cyclophosphamide, Fludarabine, Aldesleukin, Pembrolizumab




National Institutes of Health Clinical Center (CC)

Results (where available)

View Results


Published on BioPortfolio: 2019-10-28T13:57:20-0400

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