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

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.

Timeline

Start

2018-07-20

Primary completion

2023-10-31

Completion

2029-03-03

Publications

• Barisic S, Brahmbhatt EM, Cherkasova E, Spear TT, Savani U, Pierre S, Scurti GM, Chen L, Igboko M, Nadal R, Zeng G, Parry G, Stroncek DF, Highfill S, Dalheim AV, Reger R, Nishimura MI, Childs RW. Regression of renal cell carcinoma by T cell receptor-engineered T cells targeting a human endogenous retrovirus. J Immunother Cancer. 2024 Sep 11;12(9):e009147. doi: 10.1136/jitc-2024-009147.

Drugs

Indications