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NCT03197025 · ClinicalTrials.gov registry record · Phase 1
Immunotherapy With E6 T Cell Receptor (TCR) T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT03197025: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT03197025 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03197025, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
Background: Vulvar high-grade squamous intraepithelial lesion (HSIL) is caused by infection of the vulva with human papillomavirus (HPV). In a small percentage of cases, vulvar HSIL can turn into cancer. The risk of cancer can be reduced by treating HSIL. A personalized immune treatment might rid the body of HPV infection and thereby cure vulvar HSIL. The immune treatment in this study is called T cell therapy. The cells are E6 T Cell Receptor (TCR) T cells. Participants will also get aldesleukin (IL-2) to help the cells last longer. Objective: To find a safe dose of E6 TCR T cells combined with aldesleukin to use in people with vulvar HSIL. Eligibility: Design: Participants will be screened with: Physical exam Medical history Blood, lab, and pregnancy tests Heart tests Chest x-ray Sample of tissue taken from the vulva (biopsy). Participants will have leukapheresis. Blood will be removed by a needle in one arm. A machine removes white blood cells from the blood. The rest of the blood is returned by needle in the other arm. The white blood cells will be changed into E6 TCR T cells and grown in a lab. About 3 weeks later, participants will be admitted to the hospital for about 5 days. They will get the cells through a tube placed in a vein. They will get IL-2 the same way. Participants will recover 1-3 days in the hospital. They will be monitored closely. They will have blood and lab tests. Participants will have follow-up visits with lab tests and a physical exam every few months for 5 years. At some visits they will also have leukapheresis, blood tests, or vulvar biopsy.
Interventions
- DRUG Aldesleukin
- BIOLOGICAL E6 T Cell Receptor (TCR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2018-01-09 |
| Est. Completion | 2020-10-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03197025
The ClinicalTrials.gov registry entry for NCT03197025 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Aldesleukin is the first listed.
NCT03197025 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03197025 about?
NCT03197025 is a clinical study titled "Immunotherapy With E6 T Cell Receptor (TCR) T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions". Background: Vulvar high-grade squamous intraepithelial lesion (HSIL) is caused by infection of the vulva with human papillomavirus (HPV). In a small percentage of cases, vulvar HSIL can turn into cancer. The risk of cancer can be reduced by treating HSIL. A personalized immune treatment might rid t...
What is the current status of trial NCT03197025?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2018-01-09. Estimated completion is 2020-10-16.
What interventions are being tested in trial NCT03197025?
The interventions under investigation include: Aldesleukin (DRUG), E6 T Cell Receptor (TCR) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03197025?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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