Actively Recruiting
Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of the Oncolytic HSV1 MVR-C5252
Led by Duke University · Updated on 2026-04-15
51
Participants Needed
2
Research Sites
233 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1 open label study designed to assess the safety and tolerability of the oncolytic herpes simplex virus 1 (oHSV1) study drug, MVR-C5252, administered intratumorally by convection-enhanced delivery (CED) in patients with recurrent high-grade glioma. Once the safety and maximum tolerated dose (MTD) is established in the dose escalation portion of the trial, a dose expansion cohort at the recommended phase 2 dose (RP2D) in patients with isocitrate dehydrogenase (IDH) wildtype recurrent glioblastoma (GBM) will evaluate preliminary efficacy of the study drug.
CONDITIONS
Official Title
Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of the Oncolytic HSV1 MVR-C5252
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Recurrent high-grade glioma with tumor size between 1x1 cm and 3x3 cm
- For dose escalation: recurrent high-grade glioma, IDH wildtype or mutated, grade 3 or 4
- For dose expansion: recurrent, IDH wildtype glioblastoma, WHO grade 4 diagnosed by 2021 WHO CNS classification
- Neurosurgeon confirmation that tumor location is more than 1 cm from eloquent brain and infusion catheter placement is safe
- Catheter tip placement within or near enhancing tumor, at least 0.5 cm from ventricles, 1 cm deep in brain, and 0.5 cm from corpus callosum
- Tumor recurrence confirmed by histology or pre-infusion biopsy if no recent confirmation available
- Adequate lung function with pulse oximetry at least 90% on room air
- Prior standard radiation therapy plus temozolomide with resistance to this treatment
- Karnofsky Performance Status of 70% or higher
- Laboratory values meeting specified thresholds for platelets, hemoglobin, ANC, creatinine, bilirubin, AST/ALT, and coagulation
- Ability to undergo brain MRI with and without contrast
- Use of contraception during treatment and for 6 months after if sexually active and of childbearing potential
- Negative pregnancy test within 48 hours before starting treatment
- Signed informed consent approved by Institutional Review Board
You will not qualify if you...
- Prior unrelated cancer requiring active treatment except certain skin and cervical cancers
- Pregnancy or breastfeeding
- Tumor crossing midline, multifocal, infratentorial, in eloquent brain, extensive dissemination, or unsafe location per neurosurgeon
- Unstable systemic disease as judged by physician
- Active infection requiring treatment or fever above 38.1°C within 7 days before treatment
- Use of more than 4 mg dexamethasone daily within 2 weeks prior to infusion or immunosuppressive therapy within 28 days
- Incomplete standard of care treatment prior to trial
- Less than 12 weeks since radiation therapy unless specific progression criteria met
- Recent treatment with immunotherapy, chemotherapy, alkylating agents, nitrosoureas, or antiangiogenic agents within specified timeframes
- Requirement for attenuated or live vaccines within 28 days before or during treatment
- Prior treatment with oncolytic virus, cell therapy, gene therapy, or intracranial implants
- Known allergies to HSV-1, IL-12, anti-PD-1 antibodies, or study drug components
- Systemic use of anti-HSV drugs
- Cardiac risks including severe heart failure, unstable angina, serious arrhythmia, recent myocardial infarction, or myocarditis history
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Memorial Sloan Kettering
New York, New York, United States, 10065
Actively Recruiting
2
Duke University
Durham, North Carolina, United States, 27750
Actively Recruiting
Research Team
M
Mustafa Khasraw, MD
CONTACT
S
Stieve Threatt
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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