Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366490
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-28
Brief Title:
Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy in Recurrent Epithelial Ovarian Cancer
Sponsor:
PhotonPharma Inc
Organization:
PhotonPharma Inc
Study Overview
Official Title:
Phase 1 Study to Assess the Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy Administered in Patients With Recurrent Epithelial Ovarian Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Safety and Immunogenicity of InnocellTM Autologous Cellular Immunotherapy Administered in Patients with Recurrent Epithelial Ovarian Cancer
Detailed Description:
This is a Phase 1 open-label multi-center feasibility study of Innocell autologous cellular immunotherapy ie 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 10 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 10 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 BaselineGrade 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
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 10 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 10 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 BaselineGrade 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None