VRT106 plus radiotherapy in adults with DMG/DIPG

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm Phase II study enrolling adults with newly diagnosed or progressing diffuse midline glioma or DIPG. Participants will receive VRT106 injections in combination with radiotherapy, and the study will evaluate the treatment’s efficacy, safety, pharmacokinetics, and biological effects across multiple centers. The design aims to characterize preliminary signals of activity and tolerability in this difficult-to-treat population. Ongoing monitoring will include imaging and clinical assessments to track response and adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Voluntary signing of the Informed Consent Form (ICF), indicating understanding of the study and willingness and ability to comply with all study procedures.
* Male or female adults aged 18 to 75 years at the time of signing the ICF.
* Histologically or cytologically confirmed H3 K27-altered diffuse midline glioma (DMG), or a diagnosis of DIPG based on brain contrast-enhanced MRI: tumor originating in the pons, occupying \>50% of the pons volume, with diffuse brainstem enlargement.
* Karnofsky Performance Status (KPS) score ≥ 60.
* Expected survival time ≥ 3 months.

Exclusion Criteria:

* Individuals with extracranial metastases.
* Presence of spinal cord tumors or evidence of leptomeningeal disease dissemination.
* Active hemorrhage detected on cranial MRI scan prior to enrollment.
* Inability to undergo cranial MRI scanning (e.g., due to contraindications or incompatible implants).
* Prior receipt of oncolytic virus therapy or other gene therapy agents.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Yuanyuan Chen
• Email: chenyy2@sysucc.org.cn
• Phone: 202-87343543

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.