NCT05914935

Safety and Tolerability Study of Recombinant L-IFN Adenovirus Injection in Patients With Recurrent Glioblastoma

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
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Binhai Hospital of Fujian Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurring Glioblastoma

Interventions

Type	Name	Description
DRUG	Recombinant L-IFN adenovirus injection	The Ommaya reservoir was surgically implanted, and multiple intracapsular injections were given medicine. On the second day after Ommaya reservoir implantation, CT examination confirmed that the implantation was successful, and the experimental drug injection was started.

Timeline

• Start date: 2023-06-27
• Primary completion: 2024-06-12
• Completion: 2024-12-30
• First posted: 2023-06-22
• Last updated: 2023-06-28

Locations

1 site across 1 country: China