A single arm open-label pilot study is designed to determine the safety, tolerability and engraftment potential of CAR-CD19 T cells in patients with CD19-positive malignant B cell leukemia and lymphoma. All subjects will receive CAR-CD19 T cells infusion.~Primary objectives:~Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-CD19 lentiviral vector (referred to as CAR-CD19 T cells).~Determine the duration of in vivo survival of CAR-CD19 T cells.~Secondary objectives:~For patients with detectable disease, measure anti-tumor response due to CAR-CD19 T cells infusions.~To determine the amplification and survival of CAR-CD19 T 4-1BB:CD3ζ and CD28:CD3ζ as measured by the relative engraftment levels of CAR-CD19 T 4-1BB:CD3ζ and CD28:CD3ζ cells over time.~Estimate relative trafficking of CAR-CD19 T cells to tumors in bone marrow and lymphnodes.~Determine if cellular or humoral host immunity develops against the murine anti-CD19, and assess correlation with loss of detectable CAR-CD19 T (loss of engraftment).~Determine the relative subsets of CAR-CD19 T cells.
This study is designed for determining the safety and relative engraftment levels of the redirected autologous T cells transduced with the anti-CD19 lentiviral vector in patients with CD19-positive B cell leukemia and malignant lymphoma.