CompletedPhase 1/2

E7 TCR T Cells for Human Papillomavirus-Associated Cancers

United States224 participantsStarted 2017-01-27

Plain-language summary

Background: Human papillomavirus (HPV) can cause cervical, throat, anal, and genital cancers. Cancers caused by HPV have an 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 T cell receptor (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.

Who can participate

Age range18 Years – 120 Years

SexALL

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Inclusion criteria

✓. Measurable metastatic or refractory/recurrent human papillomavirus (HPV-16+ cancer (determined by in situ hybridization (ISH) or a polymerase chain reaction (PCR)-based test).
✓. Patients must be human leukocyte antigen (HLA-A\*02 by low resolution typing, and HLA-A\*02:01 by one of the high-resolution type results.
✓. All patients must have received prior first line standard therapy or declined standard therapy.
✓. Patients with three or fewer brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Patients with surgically resected brain metastases are eligible.
✓. Greater than or equal to 18 years of age.
✓. Able to understand and sign the Informed Consent Document.
✓. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1.
✓. Individuals must be willing to practice birth control from the time of enrollment on this study up to twelve (12) months after treatment. Individuals must be willing to undergo testing for HPV-16 prior to becoming pregnant after this period.

Exclusion criteria

What they're measuring

Phase II: Overall Response Rate Partial Response + Complete Response (PR +CR)

Timeframe: At 12 weeks, every 3 months x 3, and every 6 months for approximately 5 years

Phase I: Number of Dose Limiting Toxicities (DLT)

Timeframe: From the day of cell infusion (Day 0) to Day +30

Trial details

NCT IDNCT02858310

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2025-07-02

Results submitted2026-01-16

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