Clinical Trial DRUG CNDO109-001
- A Phase 1/2 Study of CNDO-109-Activated Allogeneic Natural Killer Cells in Patients with High Risk Acute Myeloid Leukemia in First Complete Remission (CR1)
- Principal Investigator
- Olga Frankfurt
- Status: COMPLETED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG CNDO109-001
- The primary objective of this study is to define the maximum tolerated dose (MTD), or the maximum tested dose of CNDO-109-Activated Allogeneic Natural Killer cells infused after preparative chemotherapy.
- This study is being done with patients who have acute myeloid leukemia (AML), are in a first complete remission and are considered to be at high risk for the AML to become active again. This is a research study of an experimental study drug, CNDO-109 Activated Allogeneic Natural Killer Cells (NK Cells). “Experimental” means that the study drug is currently being tested and is not approved for sale in the United States by the Food and Drug Administration (FDA). This study is being done to evaluate CNDO-109 Activated Allogeneic Natural Killer Cells (NK Cells) and how patients with acute myeloid leukemia (AML) respond when given this therapy. In this study, White Blood Cells are removed from a healthy donor that is a blood relative (mother, father, sister, brother, child, niece or nephew). Natural Killer cells are part of the white blood cells that are removed from the healthy donor. The Natural Killer cells are separated from the white blood cells and mixed with CNDO-109 Lysate (activated). NK cells are a type of blood cell in the immune system that attack cancer cells.
Some of the eligibility criteria include:
- Participants must have AML that is in a first complete remission.
- Participants must either not be a good candidate for, or have refuse, a stem cell transplant.
- Participants must be 18 or older.
- Participants must have an available NK cell donor.
- Description of Treatment
- Participants in this study will start their treatment with a 5 days of pre-study drug prep therapy, including the standard chemotherapy drugs fludarabine and cyclophosphamide. This regimen happens on days -6 through -2. On day 0, eligible participants receive a 10 minute infusion of the study drug.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 07-Feb-16 04:30 AM
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