Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase I Trial of T Cell Receptor Gene Therapy Targeting HPV-16 E7 With or Without PD-1 Blockade for HPV-Associated Cancers
Brief 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 of E7 TCR cells and whether these cells can help patients.
Eligibility:
Adults ages 18 66 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