Pancreatic Cancer Clinical Trial
Official title:
Pilot Study of Autologous T-cells Redirected to Mesothelin and CD19 With a Chimeric Antigen Receptor in Patients With Metastatic Pancreatic Cancer
This is a study in which pancreatic cancer patients receive a combination therapy with CART-meso cells and CART19 cells administered at 3 days after one dose of cyclophosphamide. CART-meso cells are patients' own T cells that were modified in the laboratory to express a receptor specific to the mesothelin protein. CART19 cells are patients' own T cells that were modified in the laboratory to express a receptor specific to a protein called CD19. The CD19 protein is expressed on white blood B cells. CART19 cells are expected to attack the B cells and impede the antibody response against CART-meso cells. The investigators hypothesize that this combination therapy may prolong the duration of CART-meso cells in the body. Additionally, one dose of cyclophosphamide may enhance engraftment and persistence of CART cells.
Immunotherapy is a novel and promising approach for the treatment of solid tumors;
immunotherapy with chimeric antigen receptor (CAR) T cells (CART cells) in particular has the
potential advantage of targeted therapies that can invoke a rapid tumor response, and the
advantage of long-lived responses that are the hallmark of engagement of the adaptive immune
system such as memory T cells.
This is a single arm, open-label, phase I study to determine the safety and feasibility of
combination CART-meso cells (autologous T cells lentivirally transduced to express
anti-mesothelin scFv fused to TCRζ and 4-1BB costimulatory domains) and CART19 cells
(autologous T cells lentivirally transduced to express a humanized anti-CD19 scFv fused to
TCRζ and 4-1BB costimulatory domains) in patients with pancreatic cancer following
lymphodepletion with cyclophosphamide.
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