E7 TCR T Cells for Treating Cancers Linked to Human Papillomavirus (HPV)
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02858310
This clinical trial is testing a new treatment using modified white blood cells to target and fight cancers caused by HPV, such as cervical and throat cancer. The study aims to find a safe dose and see if this approach can help patients with these cancers.
Patient Parameters
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Program Overview
This study is exploring a new treatment for cancers caused by the human papillomavirus (HPV), including cervical, throat, anal, and genital cancers. These cancers have a specific protein called E7. Researchers take a patient's blood, modify certain white blood cells to target the E7 protein, and then return these cells to the patient to help fight the cancer. The main goals are to find a safe dose and determine if this treatment can effectively help patients with HPV-related cancers.
Description
This clinical trial is focused on treating cancers associated with the human papillomavirus (HPV), specifically those with the HPV-16 type. These cancers, such as cervical, vulvar, vaginal, penile, anal, and oropharyngeal cancers, are difficult to treat with standard therapies. The new treatment involves modifying a patient's own T cells to specifically target the HPV-16 E7 protein found in these cancer cells.
The study is divided into two phases. Phase I aims to find a safe dose of the modified T cells, while Phase II will assess how well the treatment works in shrinking tumors. Participants will receive chemotherapy to prepare their bodies, followed by an infusion of the modified T cells and a medication called aldesleukin to support the treatment.
Participants will stay in the hospital for monitoring and will have follow-up visits to check their health and the treatment's effects. The study will follow participants for up to 15 years to gather long-term data.
Eligibility Criteria
Inclusion Criteria
- Have a measurable cancer linked to HPV-16 that has spread or returned after treatment.
- Be 18 years or older.
- Have a specific genetic marker called HLA-A*02:01.
- Have received standard treatment for their cancer or declined it.
- Have no more than three small brain tumors that have been treated and are stable.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Agree to use birth control during the study and for four months after treatment.
- Women must not be pregnant and must undergo a pregnancy test before starting treatment.
- Test negative for HIV, hepatitis B, and hepatitis C, or have these conditions under control with appropriate treatments.
- Have adequate blood cell counts and organ function as indicated by specific blood tests.
- Have completed any previous cancer treatments and recovered from any side effects.
- Understand the study and agree to sign informed consent.
Exclusion Criteria
- Have active infections or serious medical conditions affecting the heart, lungs, or immune system.
- Have primary immunodeficiency disorders.
- Have autoimmune diseases like Crohn's disease or lupus.
- Be taking immunosuppressive drugs, except for certain low-dose or specific types of steroids.
- Have a history of severe allergic reactions to any of the study drugs.
- Have heart problems unless cleared by a cardiac stress test.
- Have a heart's left ventricle pumping ability of 45% or lower.
- Have a baseline oxygen level below 95% on room air, unless the cause improves and is reevaluated.
- Have any condition that the study doctor believes makes participation unsafe or affects the study's integrity.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| National Institutes of Health Clinical Center | 20892 | Bethesda | Maryland |
| Rutgers Cancer Institute of New Jersey | 08901 | New Brunswick | New Jersey |
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