Safety and Activity Study of PSCA-Targeted CAR-T Cells (BPX-601) in Subjects With Selected Advanced Solid Tumors

Active:	Yes
Cancer Type:	Pancreatic Cancer Prostate Cancer	NCT ID:	NCT02744287
Trial Phases:	Phase I Phase II	Protocol IDs:	BP-012 (primary) NCI-2019-02615
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Bellicum Pharmaceuticals
NCI Full Details:	http://clinicaltrials.gov/show/NCT02744287

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.

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