Cervical Intraepithelial Neoplasia Clinical Trial
Official title:
A Phase I Study of E7 TCR T Cell Immunotherapy for High-Grade Cervical Intraepithelial Neoplasia
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04537156 -
Efficacy, Immunogenicity and Safty Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)
|
Phase 3 | |
Completed |
NCT02907333 -
Testing Use of Condoms on Regression of Cervical Intraepithelial Neoplasia
|
N/A | |
Recruiting |
NCT02576262 -
HPV Integration Testing for Human Papillomavirus-Positive Women
|
N/A | |
Completed |
NCT01029990 -
Randomized Controlled Trial to Study Interventions to Increase Participation in Cervical Cancer Screening Program
|
Phase 0 | |
Recruiting |
NCT05078528 -
Low-cost Imaging Technology for Global Prevention of Cervical Cancer
|
N/A | |
Recruiting |
NCT05502367 -
A Study of ABI-2280 Vaginal Tablet in Participants With Cervical Intraepithelial Neoplasia
|
Phase 1/Phase 2 | |
Completed |
NCT02494310 -
HRME: Screening for Cervical Cancer and Its Precursors in Low‐Resource Settings
|
N/A | |
Active, not recruiting |
NCT03429582 -
Comparison of Cervical CIN II/III Treatment Outcomes With Thermal Ablation Device
|
N/A | |
Active, not recruiting |
NCT02140021 -
Biospecimen Collection and Testing for the Prevalence of Anal Dysplasia and Anal Cancer in Patients With Cervical, Vaginal and Vulvar Dysplasia and Cancer
|
N/A | |
Not yet recruiting |
NCT05510830 -
Diagnostic Cervical Conization for Persistent Infection or Integration of HPV
|
N/A | |
Completed |
NCT02237326 -
Visual Inspection With Acetic Acid Compared to Lugol's Iodine in HIV-infected Women
|
N/A | |
Completed |
NCT00316706 -
Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine
|
Phase 3 | |
Withdrawn |
NCT03143491 -
Study of SOR007 Ointment for Cervical Intraepithelial Neoplasia (CIN)
|
Phase 2 | |
Completed |
NCT03293628 -
Comparing Two Techniques of Haemostasis After Cervical Conization
|
Phase 2 | |
Recruiting |
NCT05266898 -
Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV
|
Phase 4 | |
Completed |
NCT02481414 -
A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions
|
Phase 2 | |
Completed |
NCT02247999 -
Improving Cervical Cancer Screening Among HIV-Infected Women in India
|
||
Recruiting |
NCT04650711 -
Immunohistochemical Staining of p16 for the Screening of Cervical Cancer
|
Phase 2 | |
Recruiting |
NCT04646954 -
DNA Methylation Testing for the Screening of Uterine Cervical Lesion
|
Phase 3 | |
Completed |
NCT01544478 -
V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)
|
Phase 4 |