Safety and Activity Study of PSCA-Targeted CAR-T Cells (BPX-601) in Subjects With Selected Advanced Solid Tumors
Pancreatic Cancer
Prostate Cancer
18 Years and older, Male and Female
BP-012 (primary)
NCI-2019-02615
Summary
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.
Objectives
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.
Eligibility
- Metastatic castration-resistant prostate cancer (mCRPC), with progressive disease per PCWG3 criteria during or following the direct prior line of therapy.
- Measurable disease per RECIST v1.1 at baseline; subjects with mCRPC with bone only metastases must have measurable PSA.
- Age =18 years.
- Life expectancy > 12 weeks.
- ECOG 0-1
- Adequate organ function.
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