E7 TCR T Cells for Human Papillomavirus-Associated Cancers
Status:
Recruiting
Trial end date:
2026-01-01
Target enrollment:
Participant gender:
Summary
Background:
Human papillomavirus (HPV) can cause cervical, throat, anal, and genital cancers. Cancers
caused by HPV have a HPV protein called E7 inside of their cells. In this new therapy,
researchers take a person s blood, remove certain white blood cells, and insert genes that
make them to target cancer cells that have the E7 protein. The genetically changed cells,
called E7 TCR cells, are then given back to the person to fight the cancer. Researchers want
to see if this can help people.
Objective:
To determine a safe dose and efficacy of E7 TCR cells and whether these cells can help
patients.
Eligibility:
Adults ages 18 and older with an HPV-16-associated cancer, including cervical, vulvar,
vaginal, penile, anal, or oropharyngeal.
Design:
Participants will list all their medicines.
Participants will have many screening tests, including imaging procedures, heart and lung
tests, and lab tests. They will have a large catheter inserted into a vein.
Participants will have leukapheresis. Blood will be removed through a needle in the arm. A
machine separates the white blood cells. The rest of the blood is returned through a needle
in the other arm.
The cells will be changed in the lab.
Participants will stay in the hospital. Over several days, they will get:
Chemotherapy drugs
E7 TCR cells
Shots or injections to stimulate the cells
Participants will be monitored in the hospital up to 12 days. They will get support medicine
and have blood and lab tests.
Participants will have a clinic visit about 40 days after cell infusion. They will have a
physical exam, blood work, scans, and maybe x-rays.
Participants will have many follow-up visits with the same procedures. At some visits, they
may undergo leukapheresis.
Participants will be followed for 15 years.