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NIH Clinical Center: A Phase I Study of HERV-E TCR Transduced Autologous T Cells in Patients with Metastatic Clear Cell Renal Cell Carcinoma

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Clinical Study Summary Sheet for 18-H-0012
Summary

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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