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

Trial Status: Active

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 (pancreatic and 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.

Inclusion Criteria

  • Metastatic pancreatic cancer with tumor progression within 6 months of the most recent anti-cancer treatment and documented positive tumor expression of PSCA, and prior treatment with first or second-line therapy; or,
  • 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.

Exclusion Criteria

  • Pancreatic cancer with islet cell neoplasms or symptomatic/untreated coagulopathy.
  • Prostate cancer with unstable bone lesions or symptomatic/untreated coagulopathy, or history of > Grade 2 hematuria within the previous 6 months.
  • Prior CAR T cell or other genetically-modified T cell therapy. Prior treatment with an immune-based therapy for the treatment of prostate cancer, including cancer vaccine therapies are allowable.
  • Symptomatic, untreated, or actively progressing central nervous system metastases.
  • Impaired cardiac function or clinically significant cardiac disease.
  • Pregnant or breastfeeding.
  • Participant requires chronic, systemic steroid therapy.
  • Severe intercurrent infection.
  • Known HIV positivity.

Florida

Tampa
Moffitt Cancer Center
Status: ACTIVE

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: IN_REVIEW

New Jersey

Hackensack
Hackensack University Medical Center
Status: ACTIVE

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

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 (pancreatic or 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 (fixed dose of 0.4 mg/kg per infusion).

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.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Bellicum Pharmaceuticals

  • Primary ID BP-012
  • Secondary IDs NCI-2019-02615
  • Clinicaltrials.gov ID NCT02744287