Phase II Trial of E7 TCR-T Cell Therapy for Metastatic HPV-16 Associated Cancers

What this Trial Is About

Researchers are evaluating the clinical activity of immunotherapy using E7 TCR-T cells in adults with metastatic human papillomavirus HPV-associated cancers, including cervical, throat, penile, vulvar, vaginal, anal, and other HPV-related cancers. This phase II study focuses on patients with the HLA-A*0201 allele, which is necessary for tumor targeting by the E7 TCR. The study aims to determine tumor response rates and duration as well as collect safety data for this treatment approach. Participants will receive a conditioning regimen that includes cyclophosphamide and fludarabine, followed by a single intravenous infusion of E7 TCR-T cells, which are gene-engineered T cells targeting the HPV16 E7 oncoprotein. After the infusion, participants will receive aldesleukin administered intravenously every eight hours for up to six doses, unless certain toxicities occur or the investigator decides to stop treatment. This treatment plan is given once during the study. Throughout the study, participants will be monitored for tumor response over five years, with evaluations of adverse events collected during the same period. Assessments include measuring disease status using RECIST criteria and monitoring organ and marrow function. Participants must also comply with long-term gene therapy follow-up and biospecimen collection protocols. The overall participation duration extends through treatment and safety follow-up to assess response and side effects.

E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers