A Phase 1/2 Feasibility, Safety, and Activity Study of PSCA-Specific Chimeric Antigen Receptor Engineered T Cells (BPX-601) in Subjects With Previously Treated Advanced Solid Tumors


Condition: Pancreatic Adenocarcinoma, Gastric Adenocarcinoma, Prostate Adenocarcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02744287

Sponsor: Bellicum Pharmaceuticals

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  1. Participants with either:
  2. Metastatic pancreatic cancer with tumor progression after one prior standard chemotherapy; or,
  3. Metastatic gastric or gastroesophageal junction cancer with tumor progression after one prior standard chemotherapy; or,
  4. Hormone-refractory prostate cancer with tumor progression following treatment with a taxane-containing regimen and at least one androgen synthesis inhibitor.
  5. Tumor with positive PSCA expression as determined by central testing.
  6. Participant has a radiographically measurable tumor.
  7. Age ≥18 years
  8. 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).
  9. Participant has adequate venous access for apheresis or agree to use of a central line for apheresis collection
  10. Participant does not have significant side effects from previous anticancer treatment.
  11. Participant has adequate organ and blood cell counts.
  12. Sexually active participants must use medically acceptable methods of contraception for at least 1 year after study treatment.
  13. Participant agrees to undergo a tumor biopsy before and during treatment.

Exclusion Criteria:

  1. Pancreatic cancer with islet cell neoplasms or symptomatic coagulopathy.
  2. Gastric/GEJ with:
  3. Abnormal kidney function
  4. Non-healing wound, peptic ulcer, or bone fracture within 4 weeks of study treatment
  5. History of gastric perforation and/or fistula within 6 months of study treatment
  6. Bowel obstruction, history or presence of other inflammatory enteropathy including Crohn's disease, ulcerative colitis, or chronic diarrhea
  7. Chronic treatment with non-steroidal anti-inflammatory agents or anti-platelet agents
  8. Significant bleeding disorder
  9. Symptomatic coagulopathy
  10. Prostate cancer with unstable bone lesions or symptomatic coagulopathy.
  11. Participant has a history of major surgery or treatment with other cancer therapy within 2-4 weeks before study treatment.
  12. Participant has an untreated brain tumor.
  13. Current severe, uncontrolled systemic disease including an ongoing, active infection requiring treatment with antibiotics within 2 weeks before study treatment.
  14. History of clinically significant heart problems.
  15. Participant is currently pregnant or breastfeeding.
  16. Participant requires chronic, systemic steroid therapy.
  17. 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
  18. Participant is positive for Hepatitis B, Hepatitis C, HIV.

View trial on ClinicalTrials.gov