NIH Clinical Center: A Phase I Study of HERV-E TCR Transduced Autologous T Cells in Patients with Metastatic Clear Cell Renal Cell Carcinoma
Clinical Study Summary Sheet for 18-H-0012Summary
Number
18-H-0012
Sponsoring Institute
National Heart, Lung and Blood Institute (NHLBI)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 70
Referral Letter Required
Yes
Population Exclusion(s)
Children
Special Instructions
Currently Not Provided
Keywords
genetically modified lymphocytes;
tumor antigens;
T cell receptor immunotherapy;
genomic retroviral elements
Recruitment Keyword(s)
None
Condition(s)
Kidney Cancer
Investigational Drug(s)
HERV-E TCR
Investigational Device(s)
None
Intervention(s)
Biological/Vaccine: cell infusion
Supporting Site
National Heart, Lung, and Blood InstituteLoyola University Medical Center (LUMC)
Background:
Gene transfer is a new cancer therapy takes white blood cells from a person and grows them in a lab. The cells are changed with a virus to attack tumor cells, then returned to the person. Researchers want to see if this therapy fights kidney cancer cells.
Objective:
To see if gene transfer is safe and causes tumors to shrink.
Eligibility:
People at least 18 years old with certain kidney cancer
Design:
Participants will be screened with blood and urine tests. They may have:
-Scans
-Heart, lung, and eye tests
-Lab tests
-Tumor samples taken
Participants will have leukapheresis. Blood will be removed by a needle in an arm. It will go through a machine that removes white blood cells. Plasma and red cells will be returned through a needle in the participant s other arm.
Participants cells will be grown in the lab and genetically changed.
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