Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT06468605
Status:
WITHDRAWN
Last Update Posted:
2025-07-23
First Post:
2024-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Efficacy of JCXH-211 in Patients With Recurrent or Progressive High-Grade Glioma
Sponsor:
Duke University
Organization:
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:
WITHDRAWN
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Immorna, the funder withdrew the funds to run this study
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 2.0.
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 (AEs),and 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 (AEs),and 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:
True
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?: