The purpose of this study is to evaluate the safety and activity of BPX-601 CAR-T cells
in participants with previously treated advanced solid tumors (prostate) expressing high
levels of prostate stem cell antigen (PSCA). Participants' T cells are modified to
recognize and target the PSCA tumor marker on cancer cells.
Additional locations may be listed on ClinicalTrials.gov for NCT02744287.
See trial information on ClinicalTrials.gov for a list of participating sites.
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 (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.
Phase 1: Cell dose escalation to identify the maximum dose of BPX-601 administered with
single or repeat doses of rimiducid.
Phase 2: Indication-specific dose expansion to assess the safety, pharmacodynamics
(including BPX-601 persistence), and clinical activity at the recommended dose identified
in Phase 1 in various PSCA-expressing solid tumors.
Lead OrganizationBellicum Pharmaceuticals
