[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100434949":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":50,"centralContacts":55,"locations":65,"responsibleParty":128,"collaborators":130,"id":137,"slug":138,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":60,"eligibilityCriteria":143,"healthyVolunteers":139,"sex":144,"minAge":145,"maxAge":146,"enrollmentInfo":147,"targetDuration":60,"studyType":150,"phases":151,"briefSummary":153,"conditions":154,"keywords":157,"overallStatus":68,"whyStopped":60,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},{"fullName":5,"class":6},"Ann & Robert H Lurie Children's Hospital of Chicago","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"\"Lead In\": rHSC-DIPGVax Monotherapy","EXPERIMENTAL","rHSC-DIPGVax for 8 total doses",[13],"Biological: rHSC-DIPGVax",{"label":15,"type":10,"description":16,"interventionNames":17},"Part A: rHSC-DIPGVax in Combination with BALSTILIMAB (Anti-PD1)","rHSC-DIPGVax (8 total doses) + BALSTILIMAB (1 year of therapy or 27 cycles, whichever comes first)\n\nPatients will enroll 6-10 weeks post standard of care (SOC) radiation completion. Steroid dose must be at or below 0.5mg\u002Fkg\u002Fday for a minimum of 7 days. The first 3 patients must be 5 years or older to 18. Subsequently, subjects ages 12 months to 18 years can be enrolled. Up to six patients will be enrolled on Part A. Once safety is established for rHSC-DIPGVax plus anti-PD1 (BALSTILIMAB), the study will proceed to Part B.",[13,18],"Drug: Balstilimab",{"label":20,"type":10,"description":21,"interventionNames":22},"Part B: Dose Escalation of ZALIFRELIMAB (Anti-CTLA4)","rHSC-DIPGVax (8 total doses) + BALSTILIMAB + ZALIFRELIMAB (1 year of therapy or 9 cycles, whichever comes first)\n\nPatients will enroll 6-10 weeks post standard of care (SOC) radiation therapy. Steroid dose must be at or below 0.5mg\u002Fkg\u002Fday for a minimum of 7 days. The first 3 patients must be 5 years or older to 18. Subsequently, subjects ages 12 months to 18 years can be enrolled. Up to 12 patients will be enrolled on Part B. Once safety is established for rHSC-DIPGVax plus anti-PD1 (BALSTILIMAB) plus anti-CTLA4 (ZALIFRELIMAB), the study will proceed to Part C.",[13,18,23],"Drug: Zalifrelimab",{"label":25,"type":10,"description":26,"interventionNames":27},"Part C: Dose Expansion","rHSC-DIPGVax (8 total doses) + BALSTILIMAB + ZALIFRELIMAB (at RP2D from Part B) (1 year of therapy or 9 cycles, whichever comes first)\n\nPatients will enroll 6-10 weeks post standard of care (SOC) radiation therapy. Steroid dose must be at or below 0.5mg\u002Fkg\u002Fday for a minimum of 7 days. Up to 12 patients will be enrolled on Part C. All subjects in Part C will be monitored for DLT's for the duration of their participation in the study to monitor for excess toxicity.",[13,18,23],[29,36,44],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"BIOLOGICAL","rHSC-DIPGVax","Off-the-shelf, neoantigen heat shock protein vaccine",[9,15,20,25],[35],"vaccine",{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","Balstilimab","BALSTILIMAB is a human monoclonal antibody that targets programmed cell death 1 (PD1)",[15,20,25],[42,43],"checkpoint blockade","anti-PD1",{"type":37,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Zalifrelimab","ZALIFRELIMAB is a human monoclonal immunoglobulin G1k subclass (IgG1k) antibody that specifically recognizes cytotoxic T lymphocyte-associated protein 4 (CTLA-4, also known as CD152)",[20,25],[42,49],"anti-CTLA4",[51],{"name":52,"affiliation":53,"role":54},"Ashley Plant-Fox, MD","Ann and Robert H. Lurie Children's Hospital","PRINCIPAL_INVESTIGATOR",[56,62],{"name":57,"role":58,"phone":59,"phoneExt":60,"email":61},"Monica Newmark, BS, RN","CONTACT","312-227-4847",null,"MNewmark@luriechildrens.org",{"name":52,"role":58,"phone":63,"phoneExt":60,"email":64},"312-227-4858","aplant@luriechildrens.org",[66,90,108],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Children's Health Orange County (CHOC)","RECRUITING","Orange","California","92868","United States","US",{"type":75,"coordinates":76},"Point",[77,78],-117.85311,33.78779,{"lat":78,"lon":77},[81,85,89],{"name":82,"role":58,"phone":83,"phoneExt":60,"email":84},"Mariko Sato, MD","714-509-8636","mariko.sato@choc.org",{"name":86,"role":58,"phone":87,"phoneExt":60,"email":88},"Claudia Mousa","714-509-8724","claudia.mousa@choc.org",{"name":82,"role":54,"phone":60,"phoneExt":60,"email":60},{"facility":91,"status":68,"city":92,"state":93,"zip":94,"country":72,"countryCode":73,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Ann and Robert H. Lurie Children's Hospital of Chicago","Chicago","Illinois","60611",{"type":75,"coordinates":96},[97,98],-87.65005,41.85003,{"lat":98,"lon":97},[101,104,107],{"name":102,"role":58,"phone":103,"phoneExt":60,"email":64},"Ashley S Plant, MD","312-227-4090",{"name":105,"role":58,"phone":59,"phoneExt":60,"email":106},"Monica Newmark, BS","mnewmark@luriechildrens.org",{"name":102,"role":54,"phone":60,"phoneExt":60,"email":60},{"facility":109,"status":68,"city":110,"state":111,"zip":112,"country":72,"countryCode":73,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Dana-Farber Boston Children's Cancer and Blood Disorders Center","Boston","Massachusetts","02215",{"type":75,"coordinates":114},[115,116],-71.05977,42.35843,{"lat":116,"lon":115},[119,123,127],{"name":120,"role":58,"phone":121,"phoneExt":60,"email":122},"Alexa E Stathis","857-215-1558","alexae_stathis@dfci.harvard.edu",{"name":124,"role":58,"phone":125,"phoneExt":60,"email":126},"Susan Chi, MD","617-632-4386","susan_chi@dfci.harvard.edu",{"name":124,"role":54,"phone":60,"phoneExt":60,"email":60},{"type":129,"investigatorFullName":60,"investigatorTitle":60,"investigatorAffiliation":60,"oldNameTitle":60,"oldOrganization":60},"SPONSOR",[131,133,135],{"name":132,"class":6},"Dana-Farber Cancer Institute",{"name":134,"class":6},"Children's Hospital of Orange County",{"name":136,"class":6},"University of Calgary","100434949","phase-1-rhsc-dipgvax-plus-checkpoint-blockade-for-the-treatment-of-newly-diagnosed-dipg-and-dmg-100434949",false,"NCT04943848","rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG","A Phase I Clinical Trial of Neo-antigen Heat Shock Protein Vaccine (rHSC-DIPGVax) in Combination With Checkpoint Blockade for the Treatment of Diffuse Intrinsic Pontine Glioma (DIPG) and Diffuse Midline Glioma in Childhood","Inclusion Criteria:\n\n* Subjects with newly diagnosed typical or non-typical, biopsy-proven DIPG or DMG are eligible for study enrollment. Biopsy is not required for subjects with radiographically typical DIPG meeting imaging criteria. Biopsy is required for DMG's and non-radiographically typical DIPG. Histone mutation must be confirmed by pathology report. Radiographically typical DIPG defined as a tumor with a pontine epicenter and diffuse involvement of more than 2\u002F3 of the pons.\n\n  = Subjects ages \\> or = to 12 months and \\\u003C or = 18 years (\"Lead In\", Part A, and Part B require first three patients be \\> or = to 12 years of age)\n* BSA \\> or = 0.35m2 at the time of study enrollment\n* Performance score: Karnofsky \\>50% of subjects \\>16 years of age and Lansky \\> or = 50 for subjects \\\u003C or = 16 years of age. Subjects who are unable to walk because of paralysis but are up in a wheelchair will be considered ambulatory for the purpose of assessing the performance score.\n* Must start radiation therapy within 42 days from date of diagnostic imaging. C1D1 must be within 42 days to 70 days post radiation (6-10 weeks). Patients CANNOT receive temozolomide during radiation\n* Corticosteroids should be weaned as tolerated after radiation therapy with the goal of \\\u003C or = 0.5mg\u002Fkg\u002Fday for a minimum of 7 days prior to enrollment.\n* Subjects must have measurable disease\n\nExclusion Criteria:\n\n* Patients cannot receive temozolomide during radiation\n* Disseminated disease\n* Subjects who have received any cancer therapy except for radiation\n* Autoimmune or immune disorders\n* Active respiratory disorder or infection\n* Active viral infection","ALL","12 Months","18 Years",{"count":148,"type":149},36,"ESTIMATED","INTERVENTIONAL",[152],"PHASE1","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.",[155,156],"Diffuse Intrinsic Pontine Glioma","Diffuse Midline Glioma, H3 K27M-Mutant",[158,159,160,161,162,163,164,165,31,38,45],"Immunotherapy","Cancer vaccine","Checkpoint blockade","DIPG","Diffuse intrinsic pontine glioma","High grade glioma","DMG","Diffuse midline glioma","2026-03-16",{"date":168,"type":169},"2026-03-17","ACTUAL",{"date":171,"type":169},"2022-01-10",{"date":173,"type":149},"2027-09",{"name":5,"class":6},3]