NCT07497373

A Phase I Study to Evaluate the Safety and Tolerability of JL15003 Injection in Patients With Recurrent Glioblastoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Jecho Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, single-dose study consisting of a dose-escalation phase followed by a dose-expansion phase. Four dose levels are planned. Dose escalation will be conducted using an accelerated titration combined with a traditional "3+3" design. A total of 27 to 33 subjects are planned to be enrolled. The primary objective is to evaluate safety, with secondary objectives exploring efficacy and viral shedding. The study duration, from the first subject enrolled to the completion of the last subject's observation period (Day 57 visit), is estimated to be 1 to 2 years. A long-term survival follow-up period of approximately 15 years, or until all subjects are lost to follow-up or deceased, is planned. All data up to Day 57 will be used to support the initiation of a Phase II clinical trial. Any safety and efficacy data will be submitted to regulatory authorities on a rolling basis during the trial.

Conditions

• Recurrent Glioblastoma Multiforme(GBM)

Interventions

Type	Name	Description
BIOLOGICAL	JL15003 Injection	Single intratumoral administration of JL15003 Injection

Timeline

• Start date: 2022-11-16
• Primary completion: 2024-05-23
• Completion: 2024-05-23
• First posted: 2026-03-27
• Last updated: 2026-04-03

Locations

3 sites across 1 country: China