MVR-C5252 for Recurrent High-Grade Glioma
This study is testing a new treatment called MVR-C5252 for people with recurrent high-grade glioma (a type of brain tumor that has come back). MVR-C5252 is a modified virus that aims to fight cancer. The main goal of this Phase 1 study is to see how safe MVR-C5252 is and what side effects it might cause. Researchers will also look at how well it works. You might be able to join if you are over 18 and have a recurrent high-grade glioma of a certain size. The study is currently unclear about its recruitment status, but it plans to enroll 51 people.
- Study design
- This is a Phase 1, open-label study, meaning both you and your doctors will know which treatment you are receiving. It plans to enroll 51 participants.
- What's involved
- You would receive MVR-C5252 administered directly into the tumor. The number and timing of infusions vary by stage, with some stages involving multiple infusions over several weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures dose-limiting toxicity for up to 28 days post-infusion, or up to 56 days post-first infusion depending on the stage.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of the Oncolytic HSV1 MVR-C5252
At a glance
Conditions
Where it's being run
2 sites across 2 statesWho to contact
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What this trial measures
- Stage 1: Proportion of patients with dose-limiting toxicity (DLT) during the single infusionDay 1 of treatment until 28 days post first infusion
Proportion of patients with dose-limiting toxicity (DLT) during the single infusion
- Stage 2: Proportion of patients with dose-limiting toxicity (DLT) during 2 infusions using the internalized Ascenda catheterDay 1 of treatment until 28 days post second infusion for a total of up to 56 days post first infusion
Proportion of patients with DLT who have received two infusions on days 1 and 28
- Stage 3a: Proportion of patients with dose-limiting toxicity (DLT) after each cycle with two infusions on days 1 and 8Day 1 of treatment until 28 days post second infusion for a total of up to 35 days post first infusion
Proportion of patients with DLT who have received two infusions on days 1 and 8
- Stage 3b: Determine the MTD/RP2DDay 1 of treatment until 28 days post second infusion for a total of up to 35 days post first infusion for all the cycles for all the patients enrolled in stages 1, 2 and 3
Maximal Tolerated Dose/Recommended Phase 2 Dose (MTD/RP2D)
- Stage 4: Progression Free Survival at 6 monthsDay 1 of treatment until first documentation of disease progression or date of death, whichever comes first, assessed up to 6 months
Progression Free Survival at 6 months will be estimated by the Kaplan-Meier method