Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midli… (NCT07076498) | Clinical Trial Compass
RecruitingPhase 1
Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standard of Care Radiation
United States20 participantsStarted 2026-04-23
Plain-language summary
The goal of this clinical research study is to learn about the safety and effects of M032 given directly into the tumor in children and adults with DMG and who have received standard-of-care radiation therapy.
Who can participate
Age range36 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 36 months
* Newly diagnosed pathologically proven diffuse midline glioma (DMG) (H3 K27M mutant) or radiographic and/or pathologically proven pontine DMG (tumors with an epicenter in the pontine and diffuse involvement in at least 50% of the axial diameter of the pons)
* Patient must have received standard of care radiation ≥ 4 but ≤ 8 weeks prior to study enrollment Note: The eligibility determination, enrollment, pre-surgical planning, and M032 administration must be completed within 8 weeks of radiation therapy completion.
* The tumor characteristics for enrollment are as follows:
* The lesion must be ≥ 1.0 cm and ≤ 4.0 cm in diameter and surgically accessible as determined by MRI
* For patients diagnosed with supratentorial DMG, tumors larger than 4.0 cm may be eligible if they can be surgically debulked to ≤ 4.0 cm
* Patients must have fully recovered from acute treatment-related toxicities prior to entering this study. The study entry timepoint is defined as the time of consent
* Previous treatment guidelines (if applicable):
* Monoclonal antibody (i.e., bevacizumab): patient must have received last dose ≥ 21 days prior
* Radiation: Patients must have received their last fraction of radiation ≥ 4 weeks and ≤ 8 weeks prior to study entry
* Temozolomide: Patients must have received their last dose of chemotherapy ≥ 4 weeks prior
Normal hematological, renal, and liver function as defined below:
* Hemoglobin \> 9g/dL
* White blood cell ≥ 3,000/…
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year