Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
Background: * Vulvar high-grade squamous intraepithelial lesion (HSIL) is a premalignant epithelial lesion that is frequently multifocal and/or recurrent. * The primary treatment is surgery, which may result in disfigurement and compromise of the urethra, anus, or clitoris. Recurrence after surgery is common and primarily treated with additional surgery. * Vulvar HSIL is caused by chronic infection with the human papillomavirus (HPV) type 16 infection. In this clinical trial the HPV-16 infection is targeted with a single infusion of autologous T cells that have been genetically engineered to express a HPV-16 E7-specific T cell receptor (E7 TCR T cells). Objective: -Determine the complete response rate for E7 TCR T cells in the treatment of vulvar HSIL. Eligibility: * Histologically confirmed diagnosis of HPV-16+ vulvar HSIL. * Expression of the human leukocyte antigen (HLA)-A2\*02:01 allele. * Measurable lesion(s) that are recurrent or cannot be resected with acceptable cosmetic or functional results. * Age greater than or equal to 18 years old. * Eastern Oncology Cooperative Group Performance Score of 0 or 1. Design: * This is a phase II clinical trial * Simon minimax two-stage design with initial enrollment of 12 patients and expansion to 16 patients if one or more complete response(s) is/are observed in the initial patients. * Subjects will receive 1x10\^11 E7 TCR T cells * No conditioning regimen or aldesleukin will be given * Re-enrollment will be allowed for a small number of subjects.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
