Safety and Activity Study of PSCA-Targeted CAR-T Cells (BPX-601) in Subjects With Selected Advanced Solid Tumors
Categories (click each to see list of all clinical trials associated with that category): Cellular Therapy Support Service - CAR-T (ONC), GU (ONC)
Current Status: Open
Phase: I/II
Principal Investigator: Teply, Benjamin
Eligibility: https://clinicaltrials.gov/ct2/show/NCT02744287?term=NCT02744287&draw=2&rank=1#eligibility
Summary
Primary Objectives:
Phase 1: To determine the safety, tolerability, and maximum tolerated
dose (MTD) and/or recommended Phase II dose (RP2D) of BPX-601
administered with rimiducid to subjects with advanced solid tumors
Phase 2: To evaluate the antitumor activity of BPX-601 administered
with rimiducid in select solid tumor
Secondary Objectives:
To characterize the safety and tolerability of BPX-601 T cells
administered with rimiducid at the RP2D
To characterize the pharmacokinetics (PK) of rimiducid
To evaluate the clinical efficacy of BPX-601 T cells administered with
rimiducid in select solid tumor types
To assess the long-term safety of BPX-601 T cells
Exploratory Objectives:
To assess the immunogenicity of BPX-601 T cells
To characterize the pharmacodynamics of BPX-601 T cells
administered with and without rimiducid (e.g., expansion and
persistence of peripheral BPX-601 T cells over time)
To explore the relationship between rimiducid PK and BPX-601
pharmacodynamic biomarkers as applicable (e.g., BPX-601 T cell
persistence, phenotyping, functional activity, tumor infiltration) and
genetic and/or protein profiles in tumor tissue and peripheral blood
To explore the relationship between tumor tissue/blood-based immune
biomarkers, including serum cytokines, and clinical response or
resistance to BPX-601
To describe the PSCA expression level on tumor cells prior to CAR T
cell infusion, and the relationship it may have with disease response
and observed toxicities