2.2-2.4 - Study schema updated to more accurately reflect existing protocol procedures. 3.2 4.0 25.1 25.2 - Duke and Stanford removed from study due to underperformance and/or inability to complete all requirements to activate trial at respective sites. 5 - Projected time frame to complete study modified. 10.2 15.1 15.2.1 - Maximum steroid dose amended to more closely align with exclusion criteria in brain tumor protocols. 15.3.2 - Timing of organ performance assessment clarified. - Pulmonary function parameters that were inadvertently deleted from this section in prior protocol revision re -inserted. 15.3.2 19.4 - Modified to allow subjects to receive all available T cells if target dose is not met. This provision exists in the ICF. 17.4.2 17.4.3 - Regulatory definitions and reporting requirements for adverse events clarified . - Timeframe for following adverse events added for clarity . 17.5 - Requirements for concomitant medication collection and documentation added for clarity . 20.2 (Roadmap) - Pre-Induction or Salvage Chemo testing done as part of standard care for these patients removed. - Timeframe for pre -immunotherapy Td booster and labs clarified. 2018062 8 2.1 8.0 15.3 20.2 Study Road Map - Modify administration of GM -CSF to maintain consistent manufacturing across all of our adoptive cellular therapy trials. For the remaining subjects in this trial, we will embed the GM - CSF with the DC vaccines rather than administering intravenously. - Remove GM -CSF as part of Group A and Gr oup B consolidation of NMA chemo since it will be embedded with DC vaccine. 2.1 8.0 15.3 - Provide a window for G -CSF administration to allow for management per institutional guidelines and treating Transplant physician discretion. 3 - Remove Timothy Driscoll since Duke is no longer participating in this trial. 3.1 25 - Remove David Pincus and Barbara Frentzen who left the University of Florida and are no longer affiliated with the trial. 3.2 - Remove Stanford personnel since Stanford is no longer a participating site. Re-MATC H Protocol Page 10 of 106 Version: 20180628 4 - Remove David Pincus who left UF and is no longer affiliated with the trial. 5 - Update p rojected time frame to complete trial. 16.1 - Add provision for continued DC vaccination for subjects who have additional DC vaccines available (beyond planned 3 vaccines) and will not receive T -cell infusion either because of the inability to manufacture a viable product or failure of the product to meet release criteria. 20.2 and Study Road Map - Clarify procedures related to pre -leukapheresis laboratory assessments to allow for institutions to follow local standards (i.e., some institutions perform basic metabolic panels while others perform comprehensive metabolic panels). 20.2 - Clarify Td administration to reflect standard dosing and ensure consistency in administration across sites. Re-MATC H Protocol Page 11 of 106 Version: 20180628 LIST OF POSSIBLE ABBREVIATIONS Ab Antibody AB Alpha Beta/ Antibody ABC Automated Blood Count ABMT Autologous Bone Marrow Transplantation ACTB Beta Actin ACD Acid Citrate Dextrose ACLS Advanced Cardiac Life Support ACTH Adrenocorticot ropic Hormone AE Adverse Event AIDS Acquired Immunodeficiency Syndrome ALL Acute Lymphoblastic Leukemia ALK PHOS Alkaline Phosphatase ANOVA Analysis Of Variance Anti-HB Anti- Hepatitis B ANC Absolute Neutrophil Count ANLL Acute Non -Lymphatic Leukemia AML Acute Myelogenous Leukemia APAAP Alkaline Phosphatase Antialkaline Phosphatase Complex APC Allophycocyanin ALPS Autoimmune LymphoProliferative Syndrome ALT Autologous Lymphocyte Transfer nALT Naïve Autologous Lymphocyte Transfer xALT Ex vivo Activated Autologous Lymphocyte Transfer αCD3 anti-cell differentiation antigen 3 αIFN -γ anti-interferon alpha αTNF -α anti-tumor necrosis factor -alpha αIL2 anti-interleukin 2 AST Aspartate Aminotransferase ACTIVATE A Complementary Trial of an Immunotherapy Vaccine Against Tumor -Specific EGFRvIII AT Ambient Temperature AUC Area under the concentration time curve BD-FACS Becton -Dickinson Fluorescence Activated Cell Sorting β-HCG Beta-Human Chorionic Gonadotropin BMT Bone Marrow Transplant BMTU Bone Marrow Transplant Unit BSA Bovine Serum Albumin BSN Bachelors of Science in Nursing BTSC Brain Tumor Stem Cells BTIP Brain Tumor Immunotherapy Program BU Busulfan BUN Blood Urea Nitrogen C Chemotherapy Ca Calcium Re-MATC H Protocol Page 12 of 106 Version: 20180628 Cc Cubic Centimeters C3D Cancer Clinical Database CA California CaBIG Cancer Biomedical Informatics Grid cDNA Complimentary Deoxyribonucleic Acid CDPP Cisplatin CEA Carcinoembryonic Antigen caAEARS Cancer Adverse Event Reporting System CD133 Cell Differentiation 133 CEF Cytomegalovirus, Epstein Barr virus, Flu virus CDE Common Data Elements CFA Complete Freund’s Adjuvant CFC Cytokine Flow Cytometry CLIA Clinical Laboratory Improvement Act CMP Comprehensive Metabolic Panel CMV Cytomegalovirus CNC Clinical Neurologic Change CNS Central Nervous System CO 2 Carbon Dioxide Con-A Concanavalin A Co-PI Co-Primary Investigator CPC Cancer Protocol Committee Cr Serum Creatinine CR Complete Response CRF Conformance Review Checklist CSF Cerebro Spinal Fluid CSI Cranio spinal Irradiation CT Computed Tomography CTCAE Common Terminology Criteria for Adverse Events CTL Cytotoxic T -Lymphocyte CTLA4 Cytotoxic T-Lymphocyte Antigen 4 CTX Cyclophosphamide DC Dendritic Cell dL Deciliter DLT Dose Limiting Toxicity DLCO Diffusion Capacity of Carbon Dioxide DMSO Dimeth yl Sulfoxide DMZ Data Management Zone DNA Deoxyribonucleic Acid DNase Deoxyribonuclease D. Sci. Doctor of Science DSMB Data Safety Monitoring Board dT Diphtheria and Tetanus DTH Delayed -type Hypersensitivity DTRI Duke Translational Research Institute DUMC Duke University Medical Center Re-MATC H Protocol Page 13 of 106 Version: 20180628 EAE Experimental Autoimmune Encephalomyelitis EBRT External Beam Radiation Therapy ECHO Echocardiography EDTA Ethylenediaminetetraacetic Acid EKG Electrocardiogram EGFR Epidermal Growth Factor Receptor EGFRvIII -KLH EGFRvIII conjugated to Keyhole Limpet Hemocyanin ELISA Enzyme -Linked ImmunoSorbent Assay ELISPOT Enzyme -linked Immunospot ERADICATe Evaluation of Recovery from Drug-Induced lymphopenia using Cytomegalovirus -specific T -cell Adoptive Transfer FACS Fluorescence Activated Cell Sorting FACT -Br Functional Asses sment of Cancer Therapy for Brain Tumors FACT -accredited Foundation for the Accreditation of Cellular Therapy FDA Food and Drug Administration FEC Forced Expiratory Capacity FEV Forced Expiratory Volume FEV1 Forced Expiratory Volume at 1 second FITC Fluorescein Isothiocyanate FOXP3 Forkhead Box P3 FTP File Transfer Protocol GADPH Glyceraldehyde -3-phosphate dehydrogenase GBM Glioblastoma Multiforme GFP Green Fluorescent Protein GFR Glomerular Filtration Rate GLP Good Laboratory Pr actice G-CSF Granulocyte Colony Stimulating Factor G-Tube Gastro stomy Tube GM-CSF Granulocyte Macrophage Colony Stimulating Factor H&E Hematoxylin and Eosin HABS Human Monoclonal Antibodies HB Hepatitis B HbsAg Hepatitis B Surface Antigen HD High Dose HDC High Dose Chemotherapy hCD133 Human Cell Differentiation 133 HER2 Human Epidermal growth factor Receptor 2 hGADPH Human glyceraldehyde -3-phosphate dehydrogenase hHPRT Human Hypoxanthine Phosphoribosyltransferase HIPPA The Health Insurance Portability and Accountability Act HIV Human Immunodeficiency Virus HPRT Hypoxanthine Phosphoribosyltransferase HLA Human Leukocyte Antigens HMO Health Management Organization HSC Hematop oietic Stem Cells HVTN HIV Vaccine Trials Network Re-MATC H Protocol Page 14 of 106 Version: 20180628 IBC Institutional Biosafety Committee ICCC International Classification of Childhood Cancer IFN Interferon IFN-γ Interferon -gamma IgG Immunoglobulin G IHC Immunohistochemistry IL-1β Interleukin 1B IL-2 Interleukin -2 IL-4 Interleukin -4 IL-6 Interleukin -6 IL-12 Interleukin -12 IL-10 Interleukin -10 IL-13 Interleukin -13 IL-15 Interleukin -15 IND Investigational New Drug IP10 Human interferon -inducible protein 10 IRB Institutional Review Board IV Intravenous K Potassium Kg Kilogram KLH Keyhole Limpet Hemocyanin KLEB Poorly Differentiated Endometrial Cell Line KPS Karnofsky Performance Status L Liters LIMS Laboratory Information Management System LMD Leptomeni ngeal Disease LPS Lansky Performance Score M² Meters Squared MA Myeloablative MAb Monoclonal Antibody MAbs aCD28 Monoclonal Antibodies anti -CD28 MB Medulloblastoma MAD Maximally Achievable Dose MAGE Melanoma Antigens M.D. Medical Doctor MEL Melphalan METS Metastasis Mcg Micrograms MG Malignant Glioma Mg Magnesium Mg Milligrams MHC Major Histocompatibility Complex MIN Minutes Ml Milliliters mIU/ml Million International Units/ Milliliter MMSE Mini -Mental Status Examination Re-MATC H Protocol Page 15 of 106 Version: 20180628 MRCP Member of the Royal College of Physicians MRI Magnetic Resonance Imaging mRNA Messenger Ribonucleic Acid MTD Maximal Tolerated Dose MTIC Maximal Tolerated Inhibitory Concentration Na Sodium NA Non-adherent NC North Carolina NCC Nucleated Cell Count NDC National Documentation Center NEJM New England Journal of Medicine NEPSY Neuropsychological Assessment NCI National Cancer Institute NCI CTC National Cancer Institute Common Toxicity Criteria NG-Tube Nasogastric Tube NJ New Jersey NIAID National Institute for Allergy and Infectious Diseases NIH National Institutes of Health NINDS National Institutes of Neurological Diseases and Strokes NK Natural Killer NMA Non-Myeloablative NR Not Recorded NSC Cancer Chemotherapy National Service Center NY New York OS Overall Survival OVA Ovalbumin PALS Pediatric Advanced Life Support PBLs Peripheral Blood Lymphocytes PBMC Peripheral Blood Mononuclear Cells PBS Phosphate Buffered Saline PBSC Peripheral Blood Stem Cell PBSCT Peripheral Blood Stem Cell Transplant PBTC Pediatric Brian Tumor Consortium PBTFI Pediatric Brain Tumor Foundation Institute PCP Pneumocystis Carinii Pneumonia PCR Polymerase Chain Reaction PD Progressive Disease PE Phycoerythrin PEPvIII Peptide variant III PFS Progression Free Survival PFS-12 Progression Free Survival, 12 Months PHA Phytohemagglutinin Ph.D. Doctorate of Philosophy PHI Private Health Information PI Princip al Investigator PNETS Primitive Neuro Ectodermal Tumors Re-MATC H Protocol Page 16 of 106 Version: 20180628 PO Per Os (by mouth) polyAAA Poly Adenosine Tail PR Partial Response PRTBC Preston Robert Tisch Brain Tumor Center PT Prothrombin Time PTT Partial Thrombo plastin Time QA/QC Quality Asses sment/ Quality Control Qdot Quantum dot QOL Quality of Life ® Registered RAC Recombinant DNA Advisory Committee RE-MATCH Recurrent Medulloblastoma and Primitive Neuroectodermal Tumor A doptive T Cell Therapy during Recovery from Myeloablative C hemotherapy and H ematop oietic Stem Cell Transplantation reMB/PNETS Recurrent Medulloblastoma/Primitive Neuro Ectodermal Tumors RECIST Response Evaluation Criteria in Solid Tumors Re-START REcurrent GBM Stem cell Tumor Amplified RNA immunotherapy Trial RDC Remote Data Capture RN Registered Nurse RNA Ribonucleic Acid RPA Ribonuclease Protection Assay RPMI Roswell Park Memorial Institute RT-PCR Reverse Transcriptase Polymerase Chain Reaction Rx Treatment S Surgery SAE Serious Adverse Event SEB Staphylococcal Enterotoxin B SEER Surveillance, Epidemiology, and End Results SD Standard Deviation SD Stable Disease SGOT Serum Glutamic Oxaloacetic Transaminase SGPT Serum Glutamate Pyruvate Transaminase SH Subtractive Hybridization SIADH Syndrome of Inappropriate Antidiuretic Hormone SOP Stand ard Operating Procedure SOX2 Sex Determining Region Y Box 2 SPORE Specialized Programs of Research Excellence SPICE Specialized Program for Incredibly Complex Evaluations SQ Subcutaneous TAA -40 Top 40 Tumor Associated Antigens TAA Tumor Associated Antigens TBI Total Body Irradiation TCR T-cell Receptor Td Tetanus and Diphtheria Toxoids Re-MATC H Protocol Page 17 of 106 Version: 20180628 TERT Telomerase TGF -β1-2 Transforming Growth Factor Beta1 -2 TILs Tumor Infiltrating Ly mphocytes TLR Toll Like Receptor TM Trademark TMZ Temozolomide TNF Tumor Necrosis Factor TNF -α Tumor Necrosis Factor - Alpha Tregs Regulatory T -cells TRP-2 Tyrosinase Related Protein 2 TTP Time to Progression TTRNA Total Tumor mRNA UF University of Florida µg Micrograms µl Micro liters US United States USP United States Pharmacopeia UV Ultraviolet Vβ V Beta VCR Vincristine VICTORI Dose -Finding and Safety Study of Autologous, Tumor -Specific Antigen -Pulsed Dendritic Cell Immunotherapy for Malignant Brain Tumors VP VePesid® VP-16 Etoposide WA Washington Re-MATC H Protocol Page 18 of 106 Version: 20180628 TABLE of CONTENTS 1. STUDY TITLE .........................................................................................................21 2.