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Clinical Trial 19802

Cancer Type: Gastrointestinal Tumor
Interventions:BPX-601 (); Rimiducid ()

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Dae Won Kim

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase 1/2 Feasibility And Safety Study Of PSCA-Specific Chimeric Antigen Receptor Engineered T Cells (BPX-601) In Subjects With Non-Resectable Pancreatic Cancer

Summary

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.

Objective

Primary Objectives: To determine the safety and tolerability of BPX-601 cells administered in subjects with non-resectable pancreatic cancer. To assess the safety of the administration of the dimerizer drug, rimiducid, in subjects who have received BPX-601 cells. To determine the relationship between the administration of rimiducid and the persistence or activity of the BPX-601 T cells. To determine the maximum tolerated dose (MTD) and/or the recommended expansion dose level of BPX-601 in subjects with non-resectable pancreatic cancer.

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.