Feasibility Study of a Single Dose E7 TCR-T Cell Therapy Before Chemoradiation or Surgery for Advanced HPV-Associated Cancers

What this Trial Is About

Researchers are evaluating the use of E7 TCR-T cell induction therapy for adults with locoregionally advanced human papillomavirus HPV-associated cancers that are positive for HPV-16 and possess the HLA-A*0201 allele. This single-center study aims to see if a single dose of these genetically engineered cells can be given before standard treatments like chemoradiation or surgery without causing delays. The study focuses on tumor shrinkage, tumor response rates, and disease-free survival at 2 and 5 years. Participants will first undergo apheresis to collect their T cells, which are then modified to create E7 TCR-T cells. About one week later, they will receive a conditioning treatment with cyclophosphamide and fludarabine to prepare the body, followed by a single intravenous infusion of their engineered E7 TCR-T cells. After this, they will receive up to three doses of aldesleukin given intravenously every 8 hours as an inpatient, unless side effects require stopping the treatment. After treatment, participants return to their oncology team for further definitive therapy. During the study, participants will be monitored closely with follow-up visits at 3 and 6 weeks after the infusion to assess safety and tumor response through imaging. The main goal is to determine if the treatment can be given without delaying standard care, with additional follow-up planned to measure tumor response at 6 weeks and disease-free survival up to 5 years. Participants will also be involved in long-term gene therapy follow-up and biospecimen studies, with regular assessments of their health and tumor status throughout the study period.

E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers