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Immunotherapy With E7 T Cell Receptor T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions

NCT03937791 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2021-04-13

Study results available
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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....

Conditions

  • Squamous Lntraepithelial Lesions of Vulva
  • Neoplasms, Squamous Cell
  • Vulvar HSIL

Interventions

BIOLOGICAL

E7 T Cell Receptor (TCR)

One dose of E7 TCR T cells (1x10\^11 cells) will be administered intravenously over 20 to 30 minutes.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Scott Norberg, D.O. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-09
Primary Completion
2020-06-22
Completion
2020-06-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03937791 on ClinicalTrials.gov