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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: Recruiting Phase 1 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and HPV-Related Carcinoma, sponsored by Christian Hinrichs.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Proportion of subjects who complete treatment without an event that meets criteria for feasibility failure
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 |
What NCT05639972 shows while recruiting
NCT05639972 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 91-participant average among 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials with a reported enrollment target (84% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for HPV Positive Oropharyngeal Squamous Cell Carcinoma
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Where NCT05639972's enrollment target sits among peer trials
15 16th of 16 higher than 1 of 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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