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 (May 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
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
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