I-ATTAC Version: 20220204 1 I- ATTAC: Improved Anti -Tumor Immunotherapy Targeted Against Cytomegalovirus in Patients with Newly -Diagnosed WHO Grade IV Unmethylated Glioma ( NCT03927222) Sponsor: PI - Duke Cancer Institute Funding Source: NIH Grant Protocol Source: PI - Duke Cancer Institute Duke IRB#: Pro00090683 IND#: 16301 Principal Investigator Mustafa Khasraw, M.D . mustafa.khasraw@duke.edu Sub-Investigator(s) Annick Desjardins, M.D. annick.desjardins@duke.edu Henry Friedman, M.D. henry.friedman@duke.edu Margaret Johnson, M.D. margaret.johnson@duke.edu Katherine Peters, M.D. katherine.peters@duke.edu Kristen Batich kristen.batich@duke.edu John Sampson, M.D., Ph.D. john.sampson@duke.edu Daniel Landi, MD daniel.landi@duke.edu David Ashley , MBBS, Ph.D. david.ash ley@duke.edu Statistician James E. Herndon II, Ph.D. james.herndon@duke.edu Lead Study Coordinator Nicole Cort nicole.cort@duke.edu Regulatory Coordinator Chasiety Turner chasiety.turner@duke.edu Therapeutic Material Manufacture Manager Gary Archer, Ph.D. gary.archer@duke.edu Data Manager Eric Lipp eric.lipp@duke.edu I-ATTAC Version: 20220204 2 Version Date Description of Changes Original version: 20180108 Amended version: 20180 205 Title page for Dr. Ashley’s degrees; amended objectives/endpoints for grant submission ( Sections 8 & 15); amended total number of subjects enrolled and updated number of subjects for endpoint evaluations ( Sectio ns 9 & 12); included a CBC with all immune monitoring time points ( Section 12); clarified Td pre -conditioning dose and toxicity definition (Section 9); definition for progression & DC migration better described, as well as subclinical automimmunity included (Section 12). Amended versio n 20180316 In response to FDA information request: For Grade 3 toxicity management, immunization will be withheld until NCI CTC toxicity improves to a Grade 1 or less (Section 9.1.3 ); Amended version 20190318 CTCAE version nu mber updated to 5, Updated the missing footnote 8 (Table 4. Schedule of Events ), Title page changed the Lead clinical and regulatory coordinator, updated Sub-Investigator list, specified the size of the blood draw s in the footnotes of the table ( Table 4. Schedule of Events ), all mentions of CBC specified auto differential, We added a specification that if leukapheresis 2 must occur earlier than scheduled, that there will be a blood draw performe d at that scheduled time point, added an interim analysis in Section 15.8 , added a section on Adverse events of Special Interest ( Section 13.2) Amended version 20190529 Updated the study schema (Section 6), Updated the acceptable steroid dosage, Modified the inclusion criteria to reflect radiation requirements for eligibility (Section 11), Updated the MGMT testing details to include use of CARIS services (Section 12.1). Clarified Td booster IM can be given on the day or before vaccine #1 as long as it is given prior to vaccine#1 ( Table 4. Schedule of Events ).Updated criteria for early withdrawal to >4 weeks of RT (Section 12.6.1 ). Included details of companion leukapheresis study that can likely be used for DC vaccine manufacture (Section 10.1 12.2 ); Vaccines 4 -10 will be given every 35 (±7) days after third vaccine. Amended version 2019100 9 Dr.