This phase I study is being conducted to establish safety and feasibility of intravenous (IV) RNA mesothelin re-directed autologous T cell administration in patients with chemotherapy-refractory metastatic pancreatic cancer.~Subjects will be enrolled serially. For subject safety, the preceding subject must have completed therapy and be 28 days from their last infusion before the next subject can be treated.. Subjects will be treated with IV administration of 1 to 3e8/m2 RNA CAR T cells three times weekly (M-W-F) for three weeks.~Main eligibility criteria: Subjects with metastatic pancreatic ductal adenocarcinoma (PDA) who have chemotherapy-refractory disease. Inclusion criteria include patients older than 18 years of age diagnosed with metastatic PDA with ECOG 0-1 performance status and 3 month expected survival. Exclusion criteria include a pericardial effusion, active autoimmune disease requiring immunosuppressive therapy, active anti-coagulation therapy, known HIV or HTLV I/II positivity, prior treatment with murine monoclonal antibodies or history of allergy to murine proteins.
This is a Phase I safety and feasibility study. Subjects will be enrolled serially. For subject safety, the preceding subject must have completed one cycle of therapy (28 days) before the next subject can be treated. Subjects will be treated with i.v. administration of 1 to 3e8 per meter squared RNA CAR T cells three times weekly (M-W-F) for three weeks.