CD19 Positive Malignant B-cell Leukemia and Lymphoma Clinical Trial
Official title:
Autologous T Cells With a Chimeric Antigen Receptor in Patients With CD19-positive Malignant B Cell Leukemia and Lymphoma
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.
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:
1. 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).
2. Determine the duration of in vivo survival of CAR-CD19 T cells.
Secondary objectives:
1. For patients with detectable disease, measure anti-tumor response due to CAR-CD19 T
cells infusions.
2. 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.
3. Estimate relative trafficking of CAR-CD19 T cells to tumors in bone marrow and
lymphnodes.
4. 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).
5. Determine the relative subsets of CAR-CD19 T cells.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment