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NCT03937791 · ClinicalTrials.gov registry record · Phase 2
Immunotherapy With E7 T Cell Receptor T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT03937791: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT03937791 is a Phase 2 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
NCT03937791, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
Background: Human papillomavirus (HPV) can cause vulvar high-grade squamous intraepithelial lesions (HSIL). Sometimes, this can become cancer. Researchers want to see if T cell therapy can treat vulvar HSIL. In this therapy, a person s immune cells are genetically modified so they can attack the HPV. Objective: To test if a personalized immune treatment can cure vulvar HSIL. Eligibility: People ages 18 and older with vulvar HSIL that cannot be removed with surgery, or for which surgery has failed Design: Participants will be screened with: Medical history Physical exam HPV testing Venous assessment Chest x-ray Heart and pulmonary tests Participants will have a baseline visit. They may have a vulvar biopsy. Photographs will be taken of their lesions. Participants will have leukapheresis: Blood is removed from a needle in the arm and circulated through a machine that takes out the white blood cells. The other blood cells are returned through a needle in the other arm. The white blood cells will be used to grow treatment cells. Participants will receive the treatment through a tube inserted into an arm, neck, or chest vein. They will recover in the hospital for 1 to 2 days. They will have blood tests and take supportive medications. Participants may have one more treatment. Participants will have 5 follow-up visits in the first 3 months after treatment. They may have more visits if their disease is growing. Visits will include blood tests. They may include vulvar biopsies or leukapheresis. Participants will have an annual physical exam for 5 years after treatment that can be done at home or at the National Institutes of Health (NIH). Then they will have an annual phone or email questionnaire for another 10 years....
Interventions
- BIOLOGICAL E7 T Cell Receptor (TCR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-10-09 |
| Est. Completion | 2020-06-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03937791
The ClinicalTrials.gov registry entry for NCT03937791 describes a study currently listed as terminated, categorized as Phase 2. 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 1 intervention - of which E7 T Cell Receptor (TCR) is the first listed.
NCT03937791 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03937791 about?
NCT03937791 is a clinical study titled "Immunotherapy With E7 T Cell Receptor T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions". Background: Human papillomavirus (HPV) can cause vulvar high-grade squamous intraepithelial lesions (HSIL). Sometimes, this can become cancer. Researchers want to see if T cell therapy can treat vulvar HSIL. In this therapy, a person s immune cells are genetically modified so they can attack the HP...
What is the current status of trial NCT03937791?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2019-10-09. Estimated completion is 2020-06-22.
What interventions are being tested in trial NCT03937791?
The interventions under investigation include: E7 T Cell Receptor (TCR) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03937791?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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