To learn more about the study below, or other studies, please call us at 1-866-444-1132.

Have You Been Diagnosed with Kidney Cancer?

Researchers at the National Institutes of Health (NIH) in Bethesda, Maryland, are enrolling patients with kidney cancer (renal cell carcinoma) into a gene therapy study– a new type of precision medicine that genetically reprograms your immune cells to specifically recognize and kill tumor cells.

T cells are part of the immune system that help protect the body from infection and may help fight cancer. Too often, T cells do not recognize cancer cells or they end up becoming burned-out and lose their fighting ability. The most advanced type of cancer immunotherapy to boost your immune system is gene therapy. It consists of enhancing the T cells from the blood of a patient by genetically reprogramming them in a laboratory. These now “boostered” T cells are given back to the patient allowing the immune system to have clearer directions for recognizing and fighting cancer cells.

Dr. Richard Childs’ team discovered that the vast majority of clear-cell kidney cancers have tumor cells that express a protein called HERV-E. With this new gene therapy, we genetically reprogram your own T-cells to recognize a specific part of the HERV-E protein expressed on your kidney cancer cells that now enables these T-cells to kill your tumor cells. This is an early phase trial looking at whether this gene therapy is safe and benefits patients.

During the study:

• You will undergo leukapheresis, a process to obtain a collection of your immune cells including T cells.
• We will modify these cells in a laboratory through gene therapy to direct them against your cancer.
• You will receive chemotherapy through a vein to prepare your immune system for the modified immune cells.
• Approximately 5 weeks after the leukapheresis, you will be infused with your own immune cells, re-directed to work better at recognizing your tumor.
• You will also receive aldesleukin (IL-2) about every 12 hours for up to 14 doses so your enhanced T cells can grow and have a better chance at killing your tumor.
• You will stay at the Clinical Center, NIH’s research hospital for at least 2 weeks after the re-infusion of the boostered T-cells

You may be eligible if:

• You are 18 or older
• You have been diagnosed with kidney cancer type clear cell
• A blood tests shows you are HLA-A 11:01 positive (testing for HLA-A 11:01 can be done at the NIH)

*The HLA complex helps the immune system distinguish the body’s own proteins from proteins made by your cancer or other foreign agents (i.e. bacteria and virus).

Study-related tests, procedures, and medications are provided at no cost. Travel within the United States may be reimbursed.

Location: The NIH Clinical Center, America’s Research Hospital is located on the Metro red line (Medical Center stop) in Bethesda, Maryland.

For more information, call:
NIH Clinical Center Office of Patient Recruitment
1-866-444-1132
TTY: 1-866-411-1010
https://go.usa.gov/xnfkz
NIH study 18-H-0012