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NCT07497373: JL15003

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

Completed Phase 1 Last updated 3 April 2026
What this trial tests

Phase 1 trial testing JL15003 Injection in Recurrent Glioblastoma Multiforme(GBM) in 17 participants. Completed in 23 May 2024.

Timeline
16 November 2022
Primary endpoint
23 May 2024
23 May 2024

Quick facts

Lead sponsorJecho Biopharmaceuticals Co., Ltd.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment17
Start date16 November 2022
Primary completion23 May 2024
Estimated completion23 May 2024
Sites3 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Jecho Biopharmaceuticals Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Recurrent Glioblastoma Multiforme(GBM). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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