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ACTIVE NOT RECRUITING
NCT03354390
PHASE1

HERV-E TCR Transduced Autologous T Cells in People With Metastatic Clear Cell Renal Cell Carcinoma

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

View on ClinicalTrials.gov

Summary

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. Participants will stay in the hospital 2-3 weeks. There they will: * Get 2 chemotherapy drugs by catheter (thin plastic tube) inserted into a vein in the chest. * Get the changed cells via catheter. * Get a drug to increase white blood cell count and one to make the cells active. * Recover for about a week. * Have lab and blood tests. After leaving the hospital, participants will: * Take an antibiotic for several months. * Have leukapheresis. * Have one- or two-day clinic visits every few weeks for 2 years, and then as determined by their doctor. These will include blood and lab tests, imaging studies, and physical exam. Participants will have follow-up checks for up to 15 years.

Official title: A Phase I Study of HERV-E TCR Transduced Autologous T Cells in Patients With Metastatic Clear Cell Renal Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

17

Start Date

2018-07-20

Completion Date

2026-03-03

Last Updated

2024-12-03

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

cell infusion

This is a phase 1 trial of HERV-E TCR transduced CD8+/CD34+ T cells in HLA-A\*11:01 positive patients with metastatic ccRCC. The study is planned based on a Phase 1 3+3 dose escalation design. The maximum tolerated dose (MTD) is defined as the highest dose at which 0 or 1 patient in six has experienced a dose limiting toxicity (DLT). Patients with evaluable advanced/metastatic ccRCC will be recruited in up to 4 dose levels.

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States