E7 TCR Cell Induction Immunotherapy for Stage II and Stage III HPV-Associated Oropharyngeal Cancer

Study Summary

Background: The therapy used in this study is called E7 T-cell receptor (TCR) T cell therapy. This therapy is a type of treatment in which a participant's T cells (a type of immune system cell) are changed in the laboratory to attack cancer cells. This treatment might help people with human papillomavirus (HPV)-associated oropharyngeal cancer. Oropharyngeal cancer is a type of head and neck cancer that happens in the oropharynx (the part of the throat at the back of the mouth, including the soft palate, the base of the tongue, and the tonsils). Certain types of the HPV virus can cause this kind of cancer. This study is looking at treatments for cancer caused by HPV-16. Objective: The purpose of this study is to determine if E7 TCR T cells can be given safely without delaying standard treatment for HPV-16 associated oropharyngeal cancer. Standard treatment may be surgery or radiation therapy with chemotherapy. Eligibility: People ages 18 and older with Stage II or III HPV-16 associated oropharyngeal cancer Design: Participants will be screened with HLA typing (a blood test needed for eligibility) and HPV testing of the cancer tumor (to determine if the cancer is HPV-16 positive). A new biopsy may be needed if tumor from an outside location is not available for HPV testing. Eligible participants will come to the National Institutes of Health (NIH) campus to have a screening evaluation which will include physical exam, review of medical history and current medications, blood and heart tests, imaging (X-ray, computed tomography (CT) scan, magnetic resonance imaging (MRI) or positron emission tomography (PET) scan), and evaluation of participant's veins that are used for drawing blood. If the participant is eligible for the study based on the screening evaluation, they will have a baseline evaluation prior to receiving the experimental treatment. The baseline evaluation may include additional laboratory or imaging tests. Participants will have a large intravenous

Primary Outcome

Fraction of participants who can receive induction therapy with E7 T-Cell receptor (TCR) cells without failing the feasibility criteria with 95% confidence intervals. The feasibility criteria is defined as follows, 1) delivery of the E7 TCR T Cell induction therapy without an increase in tumor T or N stage between baseline and the last response assessment before referral for definitive treatment, 2) initiation of definitive therapy without a delay in treatment related to toxicity of the inductio

Interventions

• BIOLOGICAL E7 T-Cell Receptor (TCR)