Phase 1 Study to Assess the Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy Administered in Patients With Recurrent Epithelial Ovarian Cancer
PhotonPharma, Inc.
Summary
Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy Administered in Patients with Recurrent Epithelial Ovarian Cancer
Description
This is a Phase 1, open-label, single-center, pilot 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 3…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 years and female; 2. Has histologically or cytologically confirmed diagnosis of advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer that has received at least 1 line of platinum-based systemic therapy and for whom single-agent therapy is appropriate as the next line of treatment; 3. Been treated with available standard-of-care therapy likely to convey clinical benefit (i.e., PARP inhibitors for women with germline BRCA mutation and in homologous recombination repair deficiency based on prior molecular testing…
Interventions
- BiologicalInnocell Autologous Cellular Immunotherapy
Innocell Autologous Cellular Immunotherapy cells will be administered with CpG 1018 adjuvant ID every 2 weeks x 3 doses
Location
- City of HopeDuarte, California