This is a phase I, open label, plus expansion clinical trial evaluating the safety and tolerability of rHSC-DIPGVax in combination with BALSTILIMAB and ZALIFRELIMAB. rHSC-DIPGVax is an off-the-shelf neo-antigen heat shock protein containing 16 peptides reflecting neo-epitopes found in the majority of DIPG and DMG tumors. Newly diagnosed patients with DIPG and DMG who have completed radiation six to ten weeks prior to enrollment are eligible.
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Safety and Tolerability: Dose limiting toxicities of rHSC-DIPGVax
Timeframe: DLT period of 28 days for rHSC-DIPGVax monotherapy
Safety and Tolerability: Dose limiting toxicities of rHSC-DIPGVax plus BALSTILIMAB
Timeframe: DLT period of 28 days for Part A
Safety and Tolerability: Dose limiting toxicities of rHSC-DIPGVax plus BALSTILIMAB and ZALIFRELIMAB
Timeframe: DLT period of 42 days for Part B