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

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

Phase 1


Doctors at the National Institutes of Health and Loyola University Medical Center are recruiting participants for a study on how well a gene-modified immunotherapy can shrink renal (kidney) tumors. The investigational therapy will withdraw white blood cells (T-cells) from the patient and, utilizing gene editing, the T-cells will be modified to recognize and target their tumors. After a course of chemotherapy, the altered T-cells will be returned by IV and their growth encouraged with an additional drug. Recovery for 1 to 2 weeks in the hospital is expected, then participants will have follow-up visits every few weeks for ~2 years. Long term follow up will be continue up to 15 years.

Researchers hope to shrink tumors and to determine the best dose for treatments.


  • Be 18 to 70 years of age
  • Have confirmed renal cell cancer
  • Not be pregnant or breastfeeding
  • Patients must have a caregiver willing to stay with them during the first month of treatment (30 days +/- 7 days).
  • Meet several screening requirements regarding the status of their cancer and overall health, past treatments, and their current medications


  1. Prescreening tests to confirm eligibility of the patient to participate, including 1 to 2 weeks of repeated lab screenings
  2. Blood will be drawn via IV and a central line, or IV catheter, will be placed in the patient’s chest. T-cells will be separated from the blood cells.
  3. Over several weeks, the patient will receive no treatment while the T-cells are gene-modified in a lab
  4. One to two week stay in hospital for a course of chemotherapy to reduce the patient’s existing bone marrow.
  5. The patient’s changed cells will be re-administered along with a medicine to encourage growth of the T-cells will be administered IV twice a day for 14 doses.


The study site is at the National Institutes of Health Clinical Center in Bethesda, Maryland. Map.

Primary contact: Kristen E Wood, RN | [email protected] | (301) 827-2977

NIH Clinical Center Office of Patient Recruitment (OPR)  |  800-411-1222

TTY 866 411 1010 |  [email protected]



National Heart, Lung, and Blood Institute (NHLBI)

Loyola University Medical Center (LUMC)


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