A Phase I Study of E7 TCR T Cell Immunotherapy for High-Grade Cervical Intraepithelial Neoplasia
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Locations
- 2
- Primary Endpoint
- To determine the safety of intralesional injection of E7 TCR T cell therapy for highgrade CIN
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
To determine the safety of intralesional injection of E7 TCR T cell therapy for highgrade CIN
Time Frame: 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 Outcomes
No secondary outcomes reported