Ovarian Cancer Clinical Trial
Official title:
Phase 1 Study to Assess the Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy Administered in Patients With Recurrent Epithelial Ovarian Cancer
Safety and Immunogenicity of InnocellTM Autologous Cellular Immunotherapy Administered in Patients with Recurrent Epithelial Ovarian Cancer
This is a Phase 1, open-label, multi-center, feasibility study of Innocell autologous cellular immunotherapy (i.e., Innocell vaccine) in patients with recurrent EOC. The study is a 2-part design. For each participant, Part 1 will involve tissue procurement and confirmation of the ability to manufacture the Innocell vaccine, followed by Part 2 which is the treatment phase, involving Innocell administration to patients. Part 1 - Tissue Procurement and Manufacturing of Innocell Vaccine Participants will be screened to assure they fulfill the enrollment criteria. Screening must be performed within 30 days of administration of the Innocell regimen. Patients will undergo biopsy of the tumor. The team will target to harvest 1.0 gram or greater of tissue for the manufacturing process to produce 3 doses of Innocell and overage for testing. Upon successful manufacture and release testing the Innocell vaccine series will be initiated. Part 2 - Innocell Administration and Follow-up Participants will undergo a Baseline Visit to confirm they meet the enrollment criteria. The Baseline Visit must be performed within 30 days of planned initiation of the Innocell vaccine series. The vaccine series will consist of Innocell 1.0 x 106 cells combined with 3 mg CpG 1018 adjuvant via intradermal (ID) injection every 2 weeks (14 ±3 days) x 3 doses. Participants will be monitored for a minimum of 60 minutes following each injection, with a follow up visit 2 days (+2 days) post-each injection for evaluation of safety and tolerability. All participants who received at least 1 dose of Innocell will be followed for safety through a minimum of 30 days (+ 7 days) after the last dose of Innocell or until all treatment-related adverse events are resolved or returned to Baseline/Grade 1, whichever is longer, or until the investigator determines the outcome will not change with further followup. Blood will be drawn for evaluation of immune response and disease burden prior to each dose of Innocell, and 8 weeks post-initiation of the Innocell vaccine series. ;
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