NCT06366490

Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy for Recurrent Epithelial Ovarian Cancer

Phase 1 Study to Assess the Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy Administered in Patients With Recurrent Epithelial Ovarian Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: PhotonPharma, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy Administered in Patients with Recurrent Epithelial Ovarian Cancer

Detailed 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 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 14 days of planned initiation of the Innocell vaccine series. The vaccine series will consist of Innocell cells combined with 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 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, 2 weeks (+/- 3 days) and 30 (+7) days after the last dose of Innocell.

Conditions

• Ovarian Cancer
• Recurrent Epithelial Ovarian Cancer Which Includes Epithelial Ovarian, Fallopian Tube and/or Primary Peritoneal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Innocell Autologous Cellular Immunotherapy	Innocell Autologous Cellular Immunotherapy cells will be administered with CpG 1018 adjuvant ID every 2 weeks x 3 doses

Timeline

• Start date: 2026-02-12
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2024-04-16
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study