A Single Patient Will be Treated With Individual Patient TCR-Transduced PBL
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|ClinicalTrials.gov Identifier: NCT04194190|
Expanded Access Status : No longer available
First Posted : December 11, 2019
Last Update Posted : September 4, 2020
|Drug: Individual Patient TCR-Transduced PBL|
-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 breast cancer with autologous peripheral blood lymphocytes (PBL) that have been transduced with genes encoding T-cell receptors that recognize mutated neoantigens 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 Type :||Expanded Access|
|Expanded Access Type :||Individual Patients|
|Official Title:||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|