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A Phase 1/2 Feasibility And Safety Study Of PSCA-Specific Chimeric Antigen Receptor Engineered T Cells (BPX-601) In Subjects With Non-Resectable Pancreatic Cancer
The goal of this study is to characterize the feasibility, safety, and clinical activity of PSCA-specific CAR-T cells, BPX-601, administered with rimiducid to subjects with previously treated, PSCA-positive advanced solid tumors (pancreatic, stomach, or prostate). BPX-601 CAR-T cells are genetically engineered to express a chimeric antigen receptor (CAR) to target the PSCA antigen and a rimiducid-inducible signaling domain which functions as a molecular "go-switch" to enhance activation and proliferation.
Primary Objectives: To determine the safety and tolerability of BPX-601 cells administered in subjects with non-resectable pancreatic cancer. To assess the safety of the administration of the dimerizer drug, rimiducid, in subjects who have received BPX-601 cells. To determine the relationship between the administration of rimiducid and the persistence or activity of the BPX-601 T cells. To determine the maximum tolerated dose (MTD) and/or the recommended expansion dose level of BPX-601 in subjects with non-resectable pancreatic cancer.