M032 for Newly Diagnosed Diffuse Midline Glioma
This study is testing a treatment called M032 for children and adults with newly diagnosed diffuse midline glioma (DMG). M032 is a modified herpes virus that is injected directly into the tumor. The main goal is to see how safe M032 is and what side effects it might cause after you've already had standard radiation therapy. Researchers also want to learn if M032 can help shrink tumors or improve how long people live. You might be able to join if you are at least 3 years old, have newly diagnosed DMG (with a specific genetic change called H3 K27M mutant or in a certain brain area), and received radiation 4 to 8 weeks ago. The study is currently unclear on its recruitment status and plans to enroll 20 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 20 participants and does not specify a phase.
- What's involved
- Each patient will receive a single injection of M032 directly into their tumor. The study will assess safety and side effects through study completion, which is an average of 1 year.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety and adverse events through study completion, which is an average of 1 year.
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NCT07076498
Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standard of Care Radiation
Recruiting
PHASE1Ages 36+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~20 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:M032
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Gregory Kane Friedman Friedman, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
Hemoglobin \> 9g/dL
White blood cell ≥ 3,000/μL
Absolute neutrophil count ≥ 1000/mm3
Platelets ≥ 100,000/mm3
PT or PTT ≤ 1.3 x control
Creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min/1.73 m2 (cystatin C preferred) for patients with creatinine levels above institutional normal
Total Bilirubin ≤ 1.5 mg/dl
Transaminases \< 3 times above the upper limits of the institutional norm
Patients \< 16 years, Modified Lansky score ≥ 60; patients ≥ 16 years, Karnofsky score ≥ 60
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy.
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
History of bilateral tubal ligation or another surgical sterilization procedure.
Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of study agent administration.
Written informed consent in accordance with institutional and FDA guidelines must be obtained from the patient or legal guardian
Exclusion
Patients who previously received other investigational agents
Patients with untreated symptomatic hydrocephalus
Patients with a radiographic atypical pontine DMG or exophytic glioma, unless biopsy confirmed H3K27M alteration
Patients with a primary spinal cord tumor
Acute infection, granulocytopenia, or medical condition precluding surgery
Pregnant or lactating females: Pregnant women are excluded from this study due to the unknown potential of M032 to cause teratogenic or abortifacient effects. Lactating females are excluded from this study due to the unknown potential risk of adverse effects on both the mother and nursing infants associated with treatment using M032
Diagnosis of encephalitis or CNS infection \< 12 weeks prior
Receiving ongoing treatment for encephalitis, CNS infection, or multiple sclerosis
Tumor involvement which would require ventricular inoculation or would require access through a ventricle to deliver treatment
Patients may not be on immunosuppressive therapy (for at least 1 week), including corticosteroids at the time of enrollment. Physiological replacement of corticosteroids, intermittent use of bronchodilators, or topical steroids will not be excluded from the study.
Known HIV seropositivity or known immune deficiency
Patient with an active herpes infection with clinical symptomology
Concurrent therapy with any drug active against HSV (acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir) or any systemic immunosuppressive drug therapy (except physiological replacement of corticosteroids
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen for this trial.
Concurrent anticancer or investigational drug
Patients with medical contraindications for MRI or MRI contrast agents.
Patients who have received a live vaccine within 30 days prior to planned M032 treatment.
What this trial measures
- Safety and Adverse Events (AEs)Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0