NCT04411134

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

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cervical Intraepithelial Neoplasia

Interventions

Type	Name	Description
BIOLOGICAL	E7 TCR	Approximately 3x10\^8 or 1.5x10\^9 E7 TCR T cells will be injected on day 0 and 1.5x10\^9 E7 TCR T cells on day 31 (2 escalating dose levels)

Timeline

• Start date: 2020-05-28
• Primary completion: 2020-07-14
• Completion: 2020-07-14
• First posted: 2020-06-02
• Last updated: 2020-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study