Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-15 @ 1:22 AM
Study NCT ID:
NCT05914935
Status:
UNKNOWN
Last Update Posted:
2023-06-28
First Post:
2023-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability Study of Recombinant L-IFN Adenovirus Injection in Patients With Recurrent Glioblastoma
Sponsor:
Binhai Hospital of Fujian Medical University
Organization:
Study Overview
Official Title:
Safety、Tolerability、Pharmacokinetics and Initial Efficacy of Recombinant L-IFN Adenovirus Injection in the Treatment of Recurrent Glioblastoma：an Open-label, Single-arm, Single-center, Multi-dose Investigator-initiated Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2023-06
Last Known Status:
RECRUITING
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:
YSCH-01
Brief Summary:
The target subjects were patients with histologically or cytologically confirmed recurrent glioblastoma.Six subjects were expected to be enrolled,the number of subjects will be adjusted according to the course and outcome of the trial.The aim of this study was to evaluate the safety and tolerability of recombinant L-IFN adenovirus injection in the treatment of patients with recurrent glioblastoma, and to determine the registered clinical recommended dose and dosing regimen.
Detailed Description:
The IIT clinical study of recombinant L-IFN adenovirus injection is planned to adopt an open-label, non-randomized, dose exploratory study design. The trial was divided into screening, treatment and maintenance periods.The Ommaya reservoir was surgically implanted, and multiple intracapsular injections were administered.The overall survival (OS), progression-free survival (PFS) and disease control rate (DCR) were used to evaluate the efficacy of recombinant adenovirus L-IFN injection in the treatment of recurrent glioblastoma.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?: