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Renal Cell Cancer - Healing Genes
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Renal Cell Cancer

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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

DESCRIPTION:

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.


PATIENT MUST:

  • 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:

  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.

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]

 

SPONSOR INFORMATION:

National Heart, Lung, and Blood Institute (NHLBI)

Loyola University Medical Center (LUMC)

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03354390

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