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Protocol No. 2011IS127 Principal Investigator Cooley, Sarah
Phase Phase I/II
Age Group Adult Scope National
Title MT2012-03: 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)
Objective The primary objective is to define the maximum tolerated dose (MTD), or the maximum tested dose where multiple dose-limiting toxicities (DLTs) are not observed, of CNDO-109-Activated Allogeneic Natural Killer Cells infused after preparative chemotherapy, administered to patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1) at the time of enrollment and are considered to be at high risk for recurrence.
Treatment CNDO-109-AANK Cells Dose 1: In stage 1, patients will receive one of two doses of CNDO-109-AANK cells, and the lower of these two doses (dose 1) is 1 Million cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1 or Dose 2. CNDO-109-AANK Cells Dose 2: In stage 1, patients will receive one of two doses of CNDO-109-AANK cells, and the higher of these two doses (dose 2) is 3 Million cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1 or Dose 2.
Description This is a multi-center, open-label, non-controlled, non-randomized dose-escalating Phase 1 clinical study designed to examine the safety of infusing escalating doses of CNDO-109-Activated Allogeneic Natural Killer Cells-(from a first or second degree relative), after a preparatory chemotherapy regimen, in adult patients with acute myeloid leukemia (AML) who are in their first complete remission at the time of enrollment, are not candidates for stem cell transplant, and are considered to be at high risk for recurrence.
Key Eligibility Patient has pathologically documented acute myeloid leukemia and is in first complete remission at time of screening (within last 10 weeks).
Applicable Disease Sites Acute myeloid leukemia (AML)
Myeloid and Monocytic Leukemia
Status Open
Participating Institutions Masonic Cancer Center
Detailed Eligibility Patient must be at least 18 years of age. Patient ahs refused or is not considered an appropriate immediate candidate for transplantation and high risk for recurrence. Must have an available related NK cell donor. Anyone who has had a previous bone marrow or stem cell transplant is not eligible. Women who are pregnant or nursing are not eligible. Patient must use effective contraception and dose not have an uncontrolled infection. A signed consent form and HIPAA authorization are required.
Treatment Type Treatment
Contact Dixie Lewis Phone:612-624-4601
Email:lewis029@umn.edu
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