Actively Recruiting
Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standard of Care Radiation
Led by M.D. Anderson Cancer Center · Updated on 2026-05-05
20
Participants Needed
1
Research Sites
296 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standard of Care Radiation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 36 months or older
- Newly diagnosed diffuse midline glioma (DMG) or radiographic/pathologically proven pontine DMG
- Completed standard radiation therapy 4 to 8 weeks before enrollment
- Tumor size between 1.0 cm and 4.0 cm and surgically accessible by MRI
- For supratentorial DMG, tumors larger than 4.0 cm eligible if surgically reduced to 4.0 cm or less
- Fully recovered from acute treatment-related toxicities before study entry
- Last monoclonal antibody dose at least 21 days prior (if applicable)
- Last radiation fraction 4 to 8 weeks prior
- Last chemotherapy dose at least 4 weeks prior
- Normal blood counts and organ function within specified limits
- Modified Lansky or Karnofsky performance score 60 or higher
- Agree to use effective contraception during study participation if of child-bearing potential
- Written informed consent obtained
You will not qualify if you...
- Previous treatment with other investigational agents
- Untreated symptomatic hydrocephalus
- Atypical pontine DMG or exophytic glioma without biopsy confirmation of H3K27M alteration
- Primary spinal cord tumor
- Acute infection, granulocytopenia, or medical condition preventing surgery
- Pregnant or lactating females
- Encephalitis or CNS infection diagnosed within past 12 weeks
- Receiving treatment for encephalitis, CNS infection, or multiple sclerosis
- Tumor requiring ventricular inoculation or ventricular access for treatment delivery
- Use of immunosuppressive therapy or corticosteroids within 1 week before enrollment (except physiological replacement)
- Known HIV positive or immune deficiency
- Active symptomatic herpes infection
- Concurrent therapy with drugs active against HSV or systemic immunosuppressants
- Prior or concurrent malignancy interfering with safety or efficacy assessment
- Concurrent anticancer or investigational drugs
- Contraindications for MRI or MRI contrast agents
- Received live vaccine within 30 days prior to planned treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
G
Gregory Friedman, MD
CONTACT
K
Kara Kachurak, PNP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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