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
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
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility of the patient to participate, including 1 to 2 weeks of repeated lab screenings
- 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.
- Over several weeks, the patient will receive no treatment while the T-cells are gene-modified in a lab
- One to two week stay in hospital for a course of chemotherapy to reduce the patient’s existing bone marrow.
- 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.
LOCATIONS AND CONTACTS:
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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