Start Date
October 31, 2013
Primary Completion Date
January 31, 2017
Study Completion Date
January 31, 2017
CD3-/CD19- natural killer cells
Infused on Day 0. The final CD3-/CD19- product must contain at least 20% NK cells based on previous studies using this cell product processing technique. The entire cell product will be administered except in cases where the T cell count exceeds the T cell infusion threshold. In such situations, the product volume will be adjusted to meet the lot release criteria.
CD3-CD56+ natural killer cells
Infused on Day 0. The final CD3-/CD56+ product must contain at least 70% NK cells based on a previous study using this cell product processing technique. The entire cell product will be administered except in cases where the T cell count exceeds the T cell infusion threshold. In such situations, the product volume will be adjusted to meet the lot release criteria.
CliniMACS® CD3 and CD19 Reagent System
In combination used to simultaneously deplete CD3+ cells to remove T-lymphocytes and deplete CD19+ cells to remove B-lymphocytes (CD3-/CD19-). The entire cell product will be administered except in cases where the T cell count exceeds the T cell infusion threshold. In such situations, the product volume will be adjusted to meet the lot release criteria.
CliniMACS® CD56 Reagent System
CliniMACS® CD3 and CD19 Reagent System will be used in addition to CliniMACS® CD56 Reagent System to enrich CD56+ NK cells. The entire cell product will be administered except in cases where the T cell count exceeds the T cell infusion threshold. In such situations, the product volume will be adjusted to meet the lot release criteria.
Cyclophosphamide
Infused intravenously 60 mg/kg x day -5
Fludarabine
Fludarabine 25 mg/m2 x days -6 through -2
Aldesleukin
IL-2 subcutaneously at 6 million units every other day for 6 doses - begin evening of the NK cell infusion.
Masonic Cancer Center, University of Minnesota, Minneapolis
Washington University School of Medicine, St Louis
Collaborators (1)
Miltenyi Biomedicine GmbH
INDUSTRY
Masonic Cancer Center, University of Minnesota
OTHER