NCT04194190

A Single Patient Will be Treated With Individual Patient TCR-Transduced PBL

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

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: National Institutes of Health Clinical Center (CC) · NIH
• Sex: —
• Age: —
• Healthy volunteers: —

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.

Interventions

Type	Name	Description
DRUG	Individual Patient TCR-Transduced PBL

Timeline

• First posted: 2019-12-11
• Last updated: 2020-09-04