A Single Patient Will be Treated With Individual Patient TCR-Transduced PBL
- Registration Number
- NCT04194190
- Brief Summary
A single patient will be treated with Individual Patient TCR-Transduced PBL
- Detailed Description
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 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.
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.
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- Not specified
- Target Recruitment
- Not specified
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method