- Formatting & grammatical changes. - Modified section to indicate that the Phase I study is complete. 8 15.3.1 15.3.2 - Changed TTRNA -xALT infusion duration and vital sign monitoring. - Clarified dose of TTRNA -DCs as 1x107 cells. 15.2.1 - Corrected t ypographical error. Re-MATC H Protocol Page 4 of 106 Version: 20180628 Summary of Protocol Changes Version Date Sections Revised Purpose 16.2 - Modified section to reflect that the preparation, delivery, and administration of TTRNA -xALT will be according to Standard Operating Procedures and that subject identifiers will be double - verified prior to administration. - Changed TTRNA -xALT infusion duration and vital sign monitoring. 17.3 29.1 - Corrected grammatical error. - Modified section to reflect use of the most current CTCAE, version 4. - Modified adverse event descriptions to be consistent with CTCAE version 4. 19 - Modified title to reflect addition of “External Sites” section. 19.1 - Added new section to describe how samples will be collected/ prepared/shipped between external sites and the University of Florida. 19.2 19.3 19.5 - Modified the language in these sections (TTRNA Isolation, Amplification of RNA, and Procedure for TTRNA -DC and TTRNA -xALT Generation) to be consistent with recent changes to the Chemistry, Manufacturing, and Control section of the IND. 20.2 STUDY ROAD MAP - Modified language to indicate that the Type and Screen is only required if clinically indicated. - Modified language to indicate that oral Tums are only required if standard of care. 20140916 1130 RB 2.1 - Corrected KPS to be greater than or equal to 50% to be consistent throughout document. 10.2 11.2 13 20.1 - Added language to allow potential enrollment of subjects who have had tumor tissue snap frozen at outside institutions. 15.2.1 15.3.2 - Changed tissue transport to ‘aseptic’ to be consistent with IND. 20141013 1245 RB 10.1 - Added the ability to obtain Tissue Consent by telephone . 20141014 1240 RB 2.1 10.2 - Added carriers of Hepatitis B and/or Hepatitis C virus to exclusion criteria. 4 - Updated the name of the University of Florida study location. 17.4 17.4.1 17.4.2 17.4.3 - Added new section identifiers for reference in the Table of Contents. 17.4.3 - Defined the adverse event reporting windows. Re-MATC H Protocol Page 5 of 106 Version: 20180628 Summary of Protocol Changes Version Date Sections Revised Purpose 20.2 - Deleted reference to the Td manufacturer and injection location. - Deleted reference to Hepatitis B vaccination and titers. STUDY ROAD MAP - Deleted reference to Hepatitis B vaccination and titers. - Moved non- mobilized leukapheresis assessments before pre- induction or salvage chemo assessments to align with study activities. 23 23.1 23.2 23.3 23.4 - Added new section identifiers for reference in the Table of Contents. 23.1 - Added the University of Florida Health Cancer Center DSMB. 25 - Moved the first paragraph to Section 23.2. - Deleted the second paragraph since content is covered in Section 17.4.2. - Revised the third paragraph and moved it to Section 23.2 25.2 - Revised the fourth paragraph and moved it to Section 23.1. 26 - Deleted section since content is covered in Section 23.