E7 TCR T Cell Immunotherapy for High-Grade Cervical Intraepithelial Neoplasia
- Conditions
- Cervical Intraepithelial Neoplasia
- Interventions
- Biological: E7 TCR
- Registration Number
- NCT04411134
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Arm 1 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) Arm 2 E7 TCR The MTD from among dose level 1 and dose level 2
- Primary Outcome Measures
Name Time Method To determine the safety of intralesional injection of E7 TCR T cell therapy for highgrade CIN 3 months The fraction who experience a DLT based on the dose level and cell administration within the dose level will be determined and reported.The analysis will be entirely descriptive.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States