Ignite Creation Date:
2024-07-17 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468605
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-15
Brief Title:
Safety Tolerability and Efficacy of JCXH-211 in Patients With Recurrent or Progressive High-Grade Glioma
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Phase 1 Open-Label Study to Evaluate the Safety Tolerability and Efficacy of JCXH-211 SElf-Replicating RNA IL-12 Intratumoral Injection in Patients With Recurrent or Progressive High-Grade Glioma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SERIL
Brief Summary:
This is a phase 1 open label study to establish the safety tolerability maximum tolerated dose MTD or recommended phase 2 dose RP2D and preliminary efficacy of a single dose of JCXH-211 The study agent JCXH-211 is a self-replicating RNA srRNA-based human IL-12 administered intratumorally via convection-enhanced delivery CED to patients with recurrent or progressive high-grade glioma Primary objective is to determine MTD or RP2D for a single dose on the study drug Secondary outcomes include overall survival OS and progression-free survival PFS as assessed by modified mRANO 20
Detailed Description:
This is a Phase 1 open label study designed to assess the safety tolerability and MTD or RP2D of the study drug JCXH-211 as administered by CED in patients with recurrent or progressive high-grade glioma based on radiographic findings including patients with recurrent IDH-wildtype GBM or recurrent IDH-mutated astrocytoma who have progressed after receiving standard-of-care therapy
A stereotactic biopsy will be performed prior to administration of the study drug to confirm viable tumor and a catheter will be implanted into the appropriate site which will be confirmed by Computed Tomography CT scan post-operatively A continuous intratumoral infusion of JCXH-211 at the assigned dose level will be administered as in patient An Ommaya reservoir will also be placed in the lateral ventricle at time of surgery to remove intracranial pressure by removing CSF and collect sample for exploratory analyses
Patients will be followed up in clinic at 1 week and 2 weeks for adverse events AEsand subsequently for AEs and radiographic monitoring at 4 weeks 8 weeks and every 8 weeks thereafter until 48 weeks or disease progression whichever occurs first
A stereotactic biopsy will be performed prior to administration of the study drug to confirm viable tumor and a catheter will be implanted into the appropriate site which will be confirmed by Computed Tomography CT scan post-operatively A continuous intratumoral infusion of JCXH-211 at the assigned dose level will be administered as in patient An Ommaya reservoir will also be placed in the lateral ventricle at time of surgery to remove intracranial pressure by removing CSF and collect sample for exploratory analyses
Patients will be followed up in clinic at 1 week and 2 weeks for adverse events AEsand subsequently for AEs and radiographic monitoring at 4 weeks 8 weeks and every 8 weeks thereafter until 48 weeks or disease progression whichever occurs first
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