This is a Phase I, non-randomized, dose escalation study of the safety, biomarkers, and preliminary efficacy of dendritic cell vaccine, BPX-201, plus activating agent, AP1903, in patients with metastatic castrate resistant prostate cancer.
This is a Phase I study of therapeutic vaccine, BPX-201, plus activating agent, AP1903, in patients with mCRPC. Patients will be screened within 8 weeks prior to first vaccine administration (4 weeks prior to leukapheresis). The trial design consists of 3 cohorts of 6 patients each, receiving escalating doses of BPX-201 of 10 million (M), 20M and 40M cells, respectively. Dose escalation will occur according to a 3+3 design. Patients will receive administration of BPX-201 every other week for 6 cycles (1 cycle equals 2 weeks). Approximately 1.6 mL of BPX-201 will be administered as 8 intradermal injections (200μL each) at each treatment visit. On the day following each vaccination, a single 40 mg dose of the activating agent, AP1903, will be administered via intravenous (IV) infusion over 2 hours.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
The trial design consists of 3 cohorts of 6 patients each, receiving escalating doses of BPX-201 of 10 million (M), 20M and 40M cells, respectively. Dose escalation will occur according to a 3+3 design. Patients will receive administration of BPX-201 every other week for 6 cycles (1 cycle equals 2 weeks). Approximately 1.6 mL of BPX-201 will be administered as 8 intradermal injections (200μL each) at each treatment visit. On the day following each vaccination, a single 40 mg dose of the activating agent, AP1903, will be administered via intravenous (IV) infusion over 2 hours.
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
Baylor Charles Sammons Cancer Center
Dallas, Texas, United States
Number of Participants with adverse events as a measure of safety and tolerability
Safety will be measured through the monitoring of AEs, clinical laboratory parameters (hematology, serum chemistry, and urinalysis), vital sign measurements, and physical examinations.
Time frame: 2 years
prostatic specific antigen
Measure PSA response and PSA doubling time as measured from PSA nadir through 12 weeks
Time frame: 3 months
Progression free survival
Rate of PFS
Time frame: 2 years
Reduction in circulating tumor cells
Change from baseline in number of circulating tumor cells
Time frame: 2 years
Response to chemotherapy after vaccine
Response to chemotherapy upon progression
Time frame: 2 years
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