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NCT05639972 · ClinicalTrials.gov registry record · Phase 1
E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers
A Phase 1 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and HPV-Related Carcinoma, sponsored by Christian Hinrichs.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 2
- Study locations
NCT05639972 is a Phase 1 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and HPV-Related Carcinoma that is actively recruiting participants, run by Christian Hinrichs. The registered enrollment target is 15 participants, below the 91-participant average among 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials with a reported enrollment target (84% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT05639972, a Phase 1 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and HPV-Related Carcinoma, is actively recruiting participants, sponsored by Christian Hinrichs.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 2
- Study locations
Study 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 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.
Conditions Studied
Interventions
- DRUG Aldesleukin
- BIOLOGICAL E7 TCR-T cells
Study Locations (2)
New Jersey
- Rutgers Cancer Institute - New Brunswick
- RWJBarnabas Health - Robert Wood Johnson University Hospital - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-08-11 |
| Est. Completion | 2026-10-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05639972
The ClinicalTrials.gov registry entry for NCT05639972 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 91-participant average among 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials with a reported enrollment target (84% lower). The listed sponsor is Christian Hinrichs, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with HPV Positive Oropharyngeal Squamous Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Aldesleukin is the first listed.
NCT05639972 reports 2 study locations spanning 1 distinct geographic area - top geographies include New Jersey.
Frequently Asked Questions
What is clinical trial NCT05639972 about?
NCT05639972 is a clinical study titled "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 eliminat...
What is the current status of trial NCT05639972?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2025-08-11. Estimated completion is 2026-10-01.
What conditions does trial NCT05639972 study?
This clinical trial studies the following conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma, HPV-Related Carcinoma, HPV-Related Squamous Cell Carcinoma, HPV-Related Malignancy, HPV-Related Anal Squamous Cell Carcinoma.
What interventions are being tested in trial NCT05639972?
The interventions under investigation include: Aldesleukin (DRUG), E7 TCR-T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT05639972?
This trial is sponsored by Christian Hinrichs, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05639972 being conducted?
This trial has 2 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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