E7 TCR T Cell Immunotherapy for High-Grade Cervical Intraepithelial Neoplasia

Cervical Intraepithelial Neoplasia Clinical Trial

Official title: A Phase I Study of E7 TCR T Cell Immunotherapy for High-Grade Cervical Intraepithelial Neoplasia

Status Withdrawn

Clinical Trial Summary

Background:

Human papillomavirus (HPV) can lead to High-Grade Cervical Intraepithelial Neoplasia (CIN 2,3). This type of lesion has a high risk of becoming cancer. T cells are part of the immune system. A new type of treatment involves modifying these cells and injecting them into the lesions to shrink them.

Objective:

To test if injecting a type of treatment directly into cervical lesions can be safely given as therapy for high-grade CIN.

Eligibility:

People ages 21 and older with CIN 2,3 caused by HPV-16

Design:

Participants will be screened over at least 2 visits with:

Tumor sample

Blood and urine tests

Medical and medication history

Physical exam

Pelvic exam and colposcopy to look at the cervix

Participants will have a baseline visit. They may be admitted to the hospital. They may receive a large catheter inserted into a vein. They will have a vein assessment.

Before they receive treatment, participants will have a biopsy of the cervix. They will have leukapheresis. Blood will be removed through a needle in the arm, circulated through a machine that takes out the while blood cells, then returned through a needle in the other arm. A central catheter may also be used.

Participants will have the modified cells injected directly into their cervical lesions. They will recover in the hospital for 1-2 days.

Participants will have follow-up visits 2 weeks, 31 days, 6 weeks, and 12 weeks after treatment. They may receive a second injection at the 31-day visit.

Participants will be contacted once a year for 5 years after treatment. They will be followed for up to 15 years.

Clinical Trial Description

Background:

• Cervical Intraepithelial Neoplasia (CIN) is caused by persistent infection with the Human Papillomavirus (HPV).

• High-grade lesions are common, affecting 5% of the female population in the United States, and are more likely to progress to cervical cancer.

• Surgical and ablative therapies are effective but can lead to long-term morbidity. New treatment modalities are needed.

• E7 TCR T cells have demonstrated safety and clinical activity in treatment-refractory metastatic HPV+ cancers.

Objectives:

• To determine the safety of intralesional injection of E7 TCR T cells as therapy for high- grade CIN.

Eligibility:

• Patients greater than or equal to 21 years of age with HPV16-associated, high-grade CIN.

Design:

• This is a phase I clinical trial with a 3+3 dose escalation design.

• Patients will receive intralesional injections of E7 TCR T cells.

• Patients will not receive a conditioning chemotherapy regimen or systemic aldesleukin. ;

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Neoplasms

• NCT number: NCT04411134
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Withdrawn
• Phase: Phase 1
• Start date: May 28, 2020
• Completion date: July 14, 2020