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NCT05639972 · ClinicalTrials.gov record · last posted 2026-06-12

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

StatusRecruiting
PhasePhase 1/2
Started2025-08-11
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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 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.

Amendment record 9 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 9 times since 2022-11-28; most recent amendment 2026-06-10. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2025-03-25
Status change Not Yet RecruitingRecruitingv6
2023-10-10
Status change SuspendedNot Yet Recruitingv4
2023-03-24
Status change Not Yet RecruitingSuspendedv3
Trial Details
NCT Number NCT05639972
Lead Sponsor Christian Hinrichs
Collaborators: Iovance Biotherapeutics, Inc.
Conditions HPV-Associated Cervical Carcinoma, HPV-Related Carcinoma, HPV-Related Malignancy, HPV Positive Oropharyngeal Squamous Cell Carcinoma, HPV-Related Adenocarcinoma, HPV-Related Adenosquamous Carcinoma, HPV-Related Squamous Cell Carcinoma, HPV-Related Anal Squamous Cell Carcinoma +9 more
Enrollment 15 participants
Start Date 2025-08-11
Primary Completion 2026-10-01 (estimated)
Study Completion 2026-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-12