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

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 cells can be administered without undue delay in definitive treatment, 2) the tumor response rate to E7 TCR-T cell treatment, and 3) the disease-free survival rate at 2 and

Trial Details

NCT ID
NCT05639972
Phase
PHASE1 / PHASE2
Sponsor
Christian Hinrichs
Status
RECRUITING
Cancer Type
HPV Positive Head and Neck Cancer
Interventions
  • E7 TCR-T cells
  • Aldesleukin
Locations (sample)
  • New Brunswick, New Jersey, United States|40.48622,-74.45182
  • New Brunswick, New Jersey, United States|40.48622,-74.45182

Key Eligibility Criteria

  • Histologically confirmed carcinoma of a primary tumor site and stage indicated in Table 3 of the protocol.
  • Tumor with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.
  • HLA-A\*02:01 allele determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.…
  • Measurable disease per RECIST Criteria Version 1.1 or PERCIST.

For full eligibility, visit ClinicalTrials.gov.

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