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