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: Metastatic Castration-resistant Prostate Cancer, Metastatic Prostate Cancer, Metastatic Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer, Metastatic Pancreatic 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:

  • 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.

View trial on ClinicalTrials.gov


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