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Metastatic Cancer - Healing Genes
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Metastatic Cancer

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Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in People With Metastatic Cancer

Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in People With Metastatic Cancer


Phase 2

DESCRIPTION:
National Institutes of Health Clinical Center is recruiting patients for a trial of an investigatory gene therapy for metastatic cancers. Patients with such cancers may be eligible for this therapy that draws white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these cells with a virus which transfers a gene to help the cells recognize and attack the tumor cells before giving the cells back to the patient.

The treatment requires leukapheresis to obtain the immune cells which are then gene-modified to add the anti-tumor abilities, then after chemotherapy in the hospital, the modified cells are re-infused to the patient. After recovery, follow up includes screening tests at visits every few months for the first year, every 6 months for the second year and for up to 4 total years.


PATIENT MUST:

  • Be 18 Years to 70 years of age
  • Have metastatic or locally advanced refractory/recurrent cancer, confirmed clinically with NIH lab
  • Have previously received prior first line standard therapy that did not respond according to study’s clinical criteria

THE STUDY INVOLVES:

  1. Screening over 1-2 weeks before the treatment (including lab tests, MRIs, physical assessments, and nerve biopsies).
  2. Participants will have leukapheresis: Blood is removed by a needle in one arm. A machine removes white blood cells. The rest of the blood is returned by a needle in the other arm. An IV catheter will be placed in the chest.
  3. Care at home over 6-12 weeks.
  4. Stopping therapy for 4-6 weeks while their cells are changed in a lab.
  5. Hospital stay for 1 week to get chemotherapy by IV.
  6. Changed cells are infused by IV central line placed in step (2), followed by a drug over 1-5 days to help the cells live longer.
  7. Recover in the hospital for 1-2 weeks. Participants will get drugs and have blood and urine tests.
  8. Participants will take an antibiotic and maybe an antiviral for at least 6 months after treatment. They will have repeat screening tests at visits every few months for the first year, every 6 months for the second year, then as determined.

LOCATIONS AND CONTACTS:
Trials will take place at the National Institutes of Health Clinical Center in Bethesda, MD. Map.

Contact:
Ellen Bodurian  |  (866) 820-4505  |  [email protected]
 
SPONSOR INFORMATION:
National Cancer Institute (NCI)
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT03412877

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