Overview

E7 TCR-T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers

Status:
Not yet recruiting
Trial end date:
2026-10-01
Target enrollment:
Participant gender:
Summary
The goal of this study is to determine the feasibility of administration of a single dose of E7 TCR-T cells as induction therapy prior to definitive treatment (chemoradiation or surgery) of locoregionally advanced HPV-associated cancers. The intent of E7 TCR-T cell treatment is to shrink or eliminate tumors and thereby facilitate definitive therapy and increase overall survival. This study seeks to determine 1) if E7 TCR-T cell can be administered without undue delay in definitive treatment, 2) the tumor response rate to E7 TCR-T cell treatment, 3) and the disease-free survival rate at 2 and 5 years. Participants will undergo an apheresis procedure to obtain T cells that will be genetically engineered to generate E7 TCR-T cells. They will receive a conditioning regimen, a single infusion of their own E7 TCR-T cells, and adjuvant aldesleukin. Participants will follow up to assess safety and determine tumor response and will return to their primary oncology team for definitive therapy.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborator:
National Cancer Institute (NCI)
Treatments:
Aldesleukin