Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)
AN OPEN LABEL, SINGLE ARM TRIAL OF IMMUNOTHERAPY WITH AUTOLOGOUS ANTIGEN PRESENTING CELLS LOADED WITH PA2024 (APC8015F) FOR MEN WITH OBJECTIVE DISEASE PROGRESSION ON PROTOCOL D9902 PART B
This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B (NCT00065442)
APC8015F is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. APC8015F consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.
Inclusion Criteria: Objective disease progression Subjects must have been enrolled in the APC-Placebo arm of D9902B (NCT00065442) Exclusion Criteria: Infection requiring IV antibiotics Treatment with anticancer interventions within 14 days prior to enrollment Any medical condition which could compromise the study's objectives (discretion from sponsor)
|Event Type||Organ System||Event Term||APC8015F|
All subjects who received at least one infusion of APC8015F (N = 109) were included in the safety analysis set and were followed for safety. Refer to Serious Adverse Events and Other Adverse Events.
To compare the within-subject pre-and-post-APC8015F PSADT. The pre-and-post-APC8015F PSADT for each subject refers to the PSADT while on Protocol D9902B and Protocol PB01, respectively.
Outcome Measure Data Not Reported