Breast Cancer Clinical Trial
Official title:
Clinical Study of Chimeric CD(Cluster of Differentiation)133 Antigen Receptor-modified T Cells in Relapsed and/or Chemotherapy Refractory Malignancies
RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory
into patient autologous or donor-derived T cells may make the body build immune response to
kill cancer cells.
PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in
treating patients with Relapsed and/or Chemotherapy Refractory Advanced Malignancies.
I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced
with the anti-CD133 (cluster of differentiation antigen 133 ) vector (referred to as CART-133
cells).
II. Determine duration of in vivo survival of CART-133 cells. RT-PCR (reverse transcription
polymerase chain reaction) analysis of whole blood will be used to detect and quantify
survival of CART-133 TCR (T-cell receptor) zeta:CD137 and TCR zeta cells over time.
SECONDARY OBJECTIVES:
I. For patients with detectable disease, measure anti-tumor response due to CART-133 cell
infusions.
II. To determine if the CD137 transgene is superior to the TCR zeta only transgene as
measured by the relative engraftment levels of CART-133 TCR zeta:CD137 and TCR zeta cells
over time.
III. Estimate relative trafficking of CART-133 cells to tumor in bone marrow and lymph nodes.
IV. For patients with stored or accessible tumor cells determine tumor cell killing by
CART-133 cells in vitro.
V. Determine if cellular or humoral host immunity develops against the murine anti-CD133, and
assess correlation with loss of detectable CART-133 (loss of engraftment).
VI. Determine the relative subsets of CART-133 T cells (Tcm, Tem, and Treg).
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