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Single Patient Expanded Access
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.
Individual Patient TCR Transduced PBL, Cyclophosphamide, Fludarabine, Aldesleukin, Pembrolizumab
National Institutes of Health Clinical Center (CC)
Published on BioPortfolio: 2019-10-28T13:57:20-0400
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Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.
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