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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 (Jun 2026). This Phase 1 trial studies MVR-C5252 for recurrent high grade glioma.

Phase 1RecruitingDuke UniversityNCT06126744Data as of Jun 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

Treatments studied

Other

MVR-C5252

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.

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Related pages

Glioblastoma trials