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
- Age: minimum 18 Years maximum N/A
- Gender: All
- 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.
- 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