OncoMatch/Clinical Trials/NCT06126744
Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of the Oncolytic HSV1 MVR-C5252
Is NCT06126744 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies MVR-C5252 for recurrent high grade glioma.
Treatment: MVR-C5252 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Glioblastoma
Biomarker criteria
Allowed: IDH1 mutation
IDH wt or IDH mutated
Allowed: IDH2 mutation
IDH wt or IDH mutated
Disease stage
Required: Stage GRADE 3, GRADE 4 (WHO CNS 2021)
Grade: 34 (WHO CNS 2021)
recurrent high-grade glioma, IDH wt or IDH mutated, grade 3 or grade 4 based on imaging. Dose expansion portion: Recurrent, IDH wt, glioblastoma, WHO grade 4. Diagnosis has be made using the 2021 WHO Classification of Tumors of the CNS.
Prior therapy
Must have received: radiation therapy — standard
The subject must have received standard radiation therapy plus temozolomide and be refractory to radiation therapy plus temozolomide prior to enrollment.
Must have received: alkylating agent (temozolomide) — standard
The subject must have received standard radiation therapy plus temozolomide and be refractory to radiation therapy plus temozolomide prior to enrollment.
Cannot have received: immunotherapeutic agents
Exception: unless the patient has recovered from the expected toxic effects of such therapy
Treated with immunotherapeutic agents prior to MVR-C5252 treatment, within 4 weeks
Cannot have received: alkylating agent
Exception: unless the patient has recovered from the expected toxic effects of such therapy
alkylating agents within 4 weeks
Cannot have received: nitrosourea
Exception: unless the patient has recovered from the expected toxic effects of such therapy
nitrosoureas within 6 weeks
Cannot have received: cytotoxic chemotherapy
Exception: unless the patient has recovered from the expected toxic effects of such therapy
non-alkylating chemotherapy within 2 weeks before enrollment
Cannot have received: antiangiogenic agent (bevacizumab)
Treated with antiangiogenic agents (i.e., bevacizumab) within 4 weeks before biopsy
Cannot have received: oncolytic virus
Prior treatment with any oncolytic virus, cell therapy or gene therapy.
Cannot have received: cell therapy
Prior treatment with any oncolytic virus, cell therapy or gene therapy.
Cannot have received: gene therapy
Prior treatment with any oncolytic virus, cell therapy or gene therapy.
Cannot have received: intracranial implant (Carmustine)
Prior antitumor treatment with intracranial implants, such as Carmustine
Lab requirements
Blood counts
platelets 100,000 unsupported at initial screening, but 125,000 supported prior to biopsy/catheter insertion; hemoglobin 9 gm/dL, ANC 1000/15L; PT, aPTT 1.2 x ULN prior to biopsy (if patient is taking warfarin, INR should be obtained and be < 2.0)
Kidney function
creatinine 1.5x upper limit of normal (ULN)
Liver function
total bilirubin 1.5 x ULN, AST/ALT 2.5 x ULN (subjects with known or suspected Gilbert's syndrome are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN)
platelets 100,000 unsupported at initial screening, but 125,000 supported prior to biopsy/catheter insertion; hemoglobin 9 gm/dL, ANC 1000/15L; creatinine 1.5x upper limit of normal (ULN); total bilirubin 1.5 x ULN, AST/ALT 2.5 x ULN (subjects with known or suspected Gilbert's syndrome are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN); PT, aPTT 1.2 x ULN prior to biopsy (if patient is taking warfarin, INR should be obtained and be < 2.0)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Duke University · Durham, North Carolina
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06126744 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immunotherapeutic agents, alkylating agent, nitrosourea disqualifies patients from enrollment.
What disease stage is eligible?
Stage GRADE 3 or GRADE 4 is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages