Immunotherapy With E6 T Cell Receptor (TCR) T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions
Status:
Terminated
Trial end date:
2020-10-16
Target enrollment:
Participant gender:
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.