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Use of Ligand-Inducible Autologous T Cells Engineered to Target PSCA on Tumor Cells in 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, stomach, or 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

  • Participants with either:
  • Metastatic pancreatic cancer with tumor progression after one prior standard chemotherapy; or,
  • Metastatic gastric or gastroesophageal junction cancer with tumor progression after one prior standard chemotherapy; or,
  • Hormone-refractory prostate cancer with tumor progression following treatment with a taxane-containing regimen and at least one androgen synthesis inhibitor.
  • Tumor with positive PSCA expression as determined by central testing.
  • Participant has a radiographically measurable tumor.
  • Age ≥18 years
  • Participant has a life expectancy >12 weeks and is able to carry out daily life activities without difficulty (Eastern Cooperative Oncology Group performance status 0 or 1).
  • Participant has adequate venous access for apheresis or agree to use of a central line for apheresis collection
  • Participant does not have significant side effects from previous anticancer treatment.
  • Participant has adequate organ and blood cell counts.
  • Sexually active participants must use medically acceptable methods of contraception for at least 1 year after study treatment.
  • Participant agrees to undergo a tumor biopsy before and during treatment.

Exclusion Criteria

  • Pancreatic cancer with islet cell neoplasms or symptomatic coagulopathy.
  • Gastric/GEJ with:
  • Abnormal kidney function
  • Non-healing wound, peptic ulcer, or bone fracture within 4 weeks of study treatment
  • History of gastric perforation and/or fistula within 6 months of study treatment
  • Bowel obstruction, history or presence of other inflammatory enteropathy including Crohn's disease, ulcerative colitis, or chronic diarrhea
  • Chronic treatment with non-steroidal anti-inflammatory agents or anti-platelet agents
  • Significant bleeding disorder
  • Symptomatic coagulopathy
  • Prostate cancer with unstable bone lesions or symptomatic coagulopathy.
  • Participant has a history of major surgery or treatment with other cancer therapy within 2-4 weeks before study treatment.
  • Participant has an untreated brain tumor.
  • Current severe, uncontrolled systemic disease including an ongoing, active infection requiring treatment with antibiotics within 2 weeks before study treatment.
  • History of clinically significant heart problems.
  • Participant is currently pregnant or breastfeeding.
  • Participant requires chronic, systemic steroid therapy.
  • Participant has an active, autoimmune disease that requires immunosuppressive therapy. Exceptions are vitiligo, type I diabetes, certain cases of hypothyroidism and psoriasis, or Hashimoto's thyroiditis on a stable dose of thyroid replacement therapy
  • Participant is positive for Hepatitis B, Hepatitis C, HIV.

Florida

Tampa
Moffitt Cancer Center
Status: ACTIVE

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: IN_REVIEW

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive 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, stomach, 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 ideal safe dose of BPX-601 T cells (escalating doses from 1.25 x 10^6 cells/kg up to 5.0 x 10^6 cells/kg to be explored) 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 T cell 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