rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG
- Conditions
- Diffuse Intrinsic Pontine GliomaDiffuse Midline Glioma, H3 K27M-Mutant
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria:<br><br> - Subjects with newly diagnosed typical or non-typical, biopsy-proven DIPG or DMG are<br> eligible for study enrollment. Biopsy is not required for subjects with<br> radiographically typical DIPG meeting imaging criteria. Biopsy is required for DMG's<br> and non-radiographically typical DIPG. Histone mutation must be confirmed by<br> pathology report. Radiographically typical DIPG defined as a tumor with a pontine<br> epicenter and diffuse involvement of more than 2/3 of the pons.<br><br> = Subjects ages > or = to 12 months and < or = 18 years (Lead In, Part A, and Part<br> B require first three patients be > or = to 12 years of age)<br><br> - BSA > or = 0.35m2 at the time of study enrollment<br><br> - Performance score: Karnofsky >50% of subjects >16 years of age and Lansky > or = 50<br> for subjects < or = 16 years of age. Subjects who are unable to walk because of<br> paralysis but are up in a wheelchair will be considered ambulatory for the purpose<br> of assessing the performance score.<br><br> - Must start radiation therapy within 42 days from date of diagnostic imaging. C1D1<br> must be within 42 days to 70 days post radiation (6-10 weeks). Patients CANNOT<br> receive temozolomide during radiation<br><br> - Corticosteroids should be weaned as tolerated after radiation therapy with the goal<br> of < or = 0.5mg/kg/day for a minimum of 7 days prior to enrollment.<br><br> - Subjects must have measurable disease<br><br>Exclusion Criteria:<br><br> - Patients cannot receive temozolomide during radiation<br><br> - Disseminated disease<br><br> - Subjects who have received any cancer therapy except for radiation<br><br> - Autoimmune or immune disorders<br><br> - Active respiratory disorder or infection<br><br> - Active viral infection
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and Tolerability: Dose limiting toxicities of rHSC-DIPGVax;Safety and Tolerability: Dose limiting toxicities of rHSC-DIPGVax plus BALSTILIMAB;Safety and Tolerability: Dose limiting toxicities of rHSC-DIPGVax plus BALSTILIMAB and ZALIFRELIMAB
- Secondary Outcome Measures
Name Time Method Total number of DLT's for ZALIFRELIMAB at RP2D in combination with rHSC-DIPGVax and BALSTILIMAB;To evaluate the efficacy of the combination of rHSC-DIPGVax, BALSTILIMAB, and ZALIFRELIMB in pediatric subjects with DIPG and DMG as measured by overall survival at 12 months and time-to-progression as measured from time of diagnostic imaging;Overall survival at 1 year;Time to progression