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Ovarian Cancer - Healing Genes
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Ovarian 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:

Doctors at the National Institutes of Health are recruiting participants for a large study on how well a gene-modified immunotherapy can shrink tumors of these cancers:

  • Glioblastoma
  • Non-Small Cell Lung Cancer
  • Ovarian Cancer
  • Breast Cancer
  • Gastrointestinal/Genitourinary Cancer

The investigational therapy will withdraw white blood cells from the patient and, utilizing gene editing, the white blood cells will be taught to target their tumors. After a 1-week course of chemotherapy, the altered white blood cells will be returned by IV and their growth encouraged with additional therapy. Recovery for 1 to 2 weeks in the hospital is expected, then participants will be followed for ~2 years.


PATIENT MUST:

  • Be 18 to 70 years of age
  • Not be pregnant or breastfeeding
  • Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment
  • 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. White blood cells will be drawn via IV and a central line, or IV catheter, will be placed in the patient’s chest
  3. Over several weeks, the patient will receive no treatment while the cells are gene-modified in a lab
  4. One 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 drug over 1 to 5 days to encourage their growth
  6. After hospital discharge, an antibiotic and possibly an antiviral will be taken for at least 6 months while screening tests will be required every few months for year 1 post treatment, then each 6 months for year 2, then as determined.

LOCATIONS AND CONTACTS:

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

Primary contact: Ellen Bodurian | [email protected] | (866) 820-4505

NIH Clinical Center contact NCI/Surgery Branch Recruitment Center | [email protected] | 866-820-4505

 

SPONSOR INFORMATION:

The National Cancer Institute (NCI)

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03412877

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