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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.

Phase 1RecruitingDuke UniversityNCT06126744Data as of May 2026

Treatment: MVR-C5252This 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.

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Extracted 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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