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 Inc
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.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.