A Study of HERV-E Targeted T Cell Therapy in Patients with Advanced Kidney Cancer

Trial ID: NCT03354390
Kidney Cancer Type: Clear Cell


A T cell is a type of white blood cell. It plays an important role in the immune system by attacking virus-infected cells, foreign cells (such as bacteria), and cancer cells. However, we know that some T cells are much more effective at certain tasks than others. For this clinical trial, the researchers have developed a T cell that can specifically target and attack kidney cancer cells. They do this by targeting a molecule called “HERV-E” that is produced by kidney cancer cells, but not by healthy cells.


The purpose of this trial is to determine the safety and effectiveness of using human-designed T Cells for the treatment of patients with advanced kidney cancer. In order to participate, some of your T cells will be removed from your blood using a needle in the arm. These T cells will be sent to a lab where they will be genetically changed so that they can recognize the “HERV-E” molecule. The changed T cells will then be put back into your body, along with two chemotherapy drugs called cyclophosphamide and fludarabine.

After the infusion, you will be closely monitored and receive scans, blood tests, and urine tests every few weeks for up to two years.

Basic Eligibility:

  • Clear cell kidney cancer
  • Cancer must have spread beyond the kidney to other parts of the body
  • Patients must test positive for T-Cell Marker: HLA-A 11:01 (the researchers will send a test kit to your doctor to find out)

Additional eligibility criteria will apply. Please speak to your doctor.


This trial operates from the American National Institute of Health (NIH).
To enroll, ask your doctor to contact Tatyana Worthy at worthyt@mail.nih.gov / (301) 594-8013


Find out more about this study.
Hospital / Cancer CentrePrincipal InvestigatorLocationTrial Status
Hospital / Cancer CentreNational Institute of Health Principal InvestigatorTatyana Worthy LocationRemote Trial StatusRecruiting
Kidney Cancer Canada