MedTrace Logo

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

NCT04411134 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-07-15

No results posted yet for this study

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.

Conditions

  • Cervical Intraepithelial Neoplasia

Interventions

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)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Christian S Hinrichs, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-28
Primary Completion
2020-07-14
Completion
2020-07-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04411134 on ClinicalTrials.gov