Pancreatic Cancer Clinical Trial
Official title:
Clinical Study of Chimeric Mesothelin 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-meso vector (referred to as CART-meso cells).
II. Determine duration of in vivo survival of CART-meso cells. RT-PCR (reverse transcription
polymerase chain reaction) analysis of whole blood will be used to detect and quantify
survival of CART-meso TCR (T-cell receptor) zeta:CD137 over time.
SECONDARY OBJECTIVES:
I. For patients with detectable disease, measure anti-tumor response due to CART-meso cell
infusions.
II. Estimate relative trafficking of CART-meso cells to tumor in bone marrow and lymph
nodes.
III. For patients with stored or accessible tumor cells determine tumor cell killing by
CART-meso cells in vitro.
IV. Determine if cellular or humoral host immunity develops against the murine anti-meso,
and assess correlation with loss of detectable CART-meso (loss of engraftment).
V. Determine the relative subsets of CART-meso T cells (Tcm, Tem, and Treg).
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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