Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of the Oncolytic HSV1 MVR-C5252

Description

Oncolytic HSV1 (oHSV1) was the first viral vector studied in clinical trials to treat malignant glioma with positive outcomes for tolerability and potential clinical benefits. MVR-C5252 is a genetically modified next generation oHSV1 with an active domain of human IL-12 and Fab fragment of anti-PD-1 antibody. During viral replication, IL-12 and anti-PD-1 antibody are expressed and secreted into the tumor microenvironment, acting synergistically by increasing the T cell infiltration, converting the cold (immune suppressing) tumor to hot (immune active) tumor, and inducing anti-tumor specific immunity. This study is investigating if oHSV1 MVR-C5252 administered via CED can overcome the BBB (Blood Brain Barrier) in patients with recurrent high-grade glioma. This study will enroll patients in 4 Stages. In Stage 1, externalized Synchromed II pump will be used to deliver Gadoliunium followed by MVR-C5252 for a single administration on Day 1. Stage 2, two infusions will be administered-on days 1 and 28 via the internalized pump. For patients accrued on Stage 3, the second infusion of study drug (Cycle 1, infusion 2) will occur 7 ± 1 days after 1st infusion for a total of 6 cycles (12 infusions). Stage 4, the dose expansion portion of the study, will commence once a MTD/RP2D is established. Within Stage 4 the efficacy of the study drug, as measured by progression-free 6 months survival will be evaluated.