Re-MATCH: Recurrent Medulloblastoma and Primitive Neuroectodermal Tumor Adoptive T Cell Therapy during Recovery from Myeloablative Chemotherapy and H ematopoietic Stem Cell Transplantation Food and Drug Administration Investigation al New Drug Application 14,058 University of Florida Institutional Review Board Protocol 201500502 (Previously 128- 2013 ) Duane A. Mitchell, M.D., Ph.D. (Principal Investigator) Re-MATC H Protocol Page 2 of 106 Version: 20180628 Summary of Protocol Changes Version Date Sections Revised Purpose 20130913 1230 RB N/A - Initial UF Protocol Release 20140410 0800 RB Entire Document - Re-formatted for improved readability - Corrected typographical errors Title Page - Added IRB number - Deleted non -UF investigators List of Possible Abbreviations - Added Myeloablative (MA) 2 - Clarified how subjects will be analyzed Study Synopsis - Clarified the primary and secondary objectives - Limited inclusion to first localized recurrence - Clarified the study design - Added language to outline the timing for non -mobilized leukapheresis - Clarified use and timing of GM -CSF and G -CSF 3 - Updated titles and work location s - Added Jianping Huang, MD, PhD 4 - Updated locations and amended the list of supervising personnel 5 - Updated to reflect completion of reviews and approvals - Updated to reflect new study completion time frame 6 - Removed reference to the Phase I Aims since th at portion of the study was completed at Duke University - Updated Phase I study data - Limited inclusion to first localized recurrence 7 - Clarified the primary and secondary objectives 8 - Clarified the primary efficacy endpoint and how subjects will be analyzed - Added language to outline the timing for non -mobilized leukapheresis - Clarified use and timing of GM -CSF and G -CSF 9 - Limited inclusion to first localized recurrence 10 - Limited inclusion to first localized recurrence - Clarified eligibility criteria for cardiac parameters - Deleted reference to Phase I of the study 11 - Deleted reference to Duke personnel 14 - Deleted requirement for signed and dated eligibility checklist before enrollment Re-MATC H Protocol Page 3 of 106 Version: 20180628 Summary of Protocol Changes Version Date Sections Revised Purpose 15 - Added language to outline the timing for non -mobilized leukapheresis - Amended language for PBSC mobilization and leukapheresis to outline the collection goals for leukapheresis and TTRNA and DC vaccine - Clarified eligibility criteria for cardiac parameters 17 - Clarified types of events requiring prompt reporting 19 - Amended language for PBSC mobilization and leukapheresis to outline the collection goals for leukapheresis and TTRNA and DC vaccine 20 - Updated shipping address for pathology slides - Clarified which infectious disease markers are required Study Road Map - Revised and expanded to include all study requirements referenced in other sections of the protocol 21 - Added language to indicate that samples collected at Duke from Phase I subjects will be analyzed at UF with Phase II samples - Clarified the starting point for survival analysis - Deleted reference to Duke follow -up trac k record 22 - Removed all reference to Duke's Safety Oversight Committee and Regulatory Officer and added language related to the use and role of an independent external monitor 24 - Deleted reference to Duke’s Phase I RE -START protocol - Amended monthly P I meeting to conference calls 26 - Removed reference to Regulatory Officer and added language related to the use of an independent external monitor 2014080 8 0830 RB 2.1 - Clarified dose of TTRNA -DCs as 1x10 7 cells. 6.1 - Replaced “our institution” with “Duke University” since Dr.