Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-07 @ 10:29 PM
Study NCT ID:
NCT04411134
Status:
WITHDRAWN
Last Update Posted:
2020-07-15
First Post:
2020-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
E7 TCR T Cell Immunotherapy for High-Grade Cervical Intraepithelial Neoplasia
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase I Study of E7 TCR T Cell Immunotherapy for High-Grade Cervical Intraepithelial Neoplasia
Status:
WITHDRAWN
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed based on the lack of perceived clinical activity observed from a different study treating a similar patient population with same study agent.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 20-C-0093 | None | None | View |