Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*1101 Patients
Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A 1101 Patients
Doctors at the National Institutes of Health Clinical Center seek to enroll patients in a clinical trial to treat the following cancers that have been treated without success, or with recurrence, or those who declined treatment altogether::
- Pancreatic Cancer
- Gastric Cancer
- Gastrointestinal Cancer
- Colon Cancer
- Rectal Cancer
The investigatory treatment targets cancers that carry a particular genetic mutation, and the therapy involves a genetic modification of the patient’s immune cells in the lab to recognize and kill their cancer. The study will require blood draw to isolate the desired immune cells and, once gene-modification is complete and after a course of chemotherapy, participants will receive their modified immune cells and a drug to help them replicate. Recovery at the hospital is estimated at 12 weeks, and follow up will continue for several years.
- Be 18 years to 70 of age
- Be diagnosed with one of the eligible cancers, with DNA tests to confirm subtype required
- Agree to contraception for at least 4 months after the immunotherapy
- Be HIV negative
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility of the patient to participate.
- Have blood drawn, immune cells separated and blood cells returned (leukapheresis)
- After lab modification time, the patient will be admitted to the hospital and receive chemotherapy over 5 days.
- A few days later, the gene-edited immune cells will be infused and drugs to help promote their growth injected.
- Recovery in the hospital for 12 weeks.
- Visits every few months x 2 years for 1 to 2 days each.
- Blood samples to be drawn over the next several years.
LOCATIONS AND CONTACTS:
The study site is at the National Institutes of Health Clinical Center in Bethesda, Maryland. Map.
Contact: Ellen Bodurian | (866) 820-4505 | [email protected]
The National Cancer Institute (NCI)
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