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Clinical Trial 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.


Clinical Trial Description

This is a single-arm, single-cohort, single-center, feasibility study to determine the feasibility of E7 TCR-T cell induction therapy for locoregionally advanced human papillomavirus (HPV)-associated cancers (LAHPVC). Participants must have LAHPVC with HPV-16-positive cancer (tumor test) and the human leukocyte antigens (HLA)-A*02:01 allele (blood test). Participants will undergo apheresis for generation of autologous, gene-engineered, E7 TCR-T cells. One week after apheresis, they will receive a non-myeloablative lymphocyte-depleting preparative regimen of cyclophosphamide and fludarabine. Conditioning will be followed by a single infusion of E7 TCR T cells and adjuvant high-dose aldesleukin. Participants will follow up 3 weeks and 6 weeks after treatment. Tumor response will be assessed by imaging studies at the 6-week time point. Participants will be referred back to their primary oncology team for definitive therapy after the 6-week assessment (or earlier if tumors do not appear to be responding). Participants will be followed to determine 2- and 5-year disease free survival. ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Anal Cancer
  • Anus Neoplasms
  • Carcinoma
  • Carcinoma, Adenosquamous
  • Carcinoma, Squamous Cell
  • Cervical Cancer
  • HPV Positive Oropharyngeal Squamous Cell Carcinoma
  • HPV-Related Anal Squamous Cell Carcinoma
  • HPV-Related Carcinoma
  • HPV-Related Malignancy
  • HPV-Related Penile Squamous Cell Carcinoma
  • HPV-Related Squamous Cell Carcinoma
  • HPV-Related Vulvar Squamous Cell Carcinoma
  • Oropharyngeal Neoplasms
  • Oropharynx Cancer
  • Penile Cancer
  • Penile Neoplasms
  • Squamous Cell Carcinoma of Head and Neck
  • Uterine Cervical Neoplasms
  • Vaginal Cancer
  • Vaginal Neoplasms
  • Vulvar Cancer
  • Vulvar Neoplasms

NCT number NCT05639972
Study type Interventional
Source Rutgers, The State University of New Jersey
Contact Christian S Hinrichs, MD
Phone 732-235-9806
Email ch977@cinj.rutgers.edu
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date June 12, 2024
Completion date October 1, 2026

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