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 Recruiting→Recruitingv6
2023-10-10
Status change Suspended→Not Yet Recruitingv4
2023-03-24
Status change Not Yet Recruiting→Suspendedv3
| 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 |