Safety and Activity Study of PSCA-Targeted CAR-T Cells (BPX-601) in Subjects With Selected Advanced Solid Tumors
- 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.
- 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.
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
- Primary ID BP-012
- Secondary IDs NCI-2019-02615
- Clinicaltrials.gov ID NCT02744287