annick.desjardins@dm.duke.edu Henry Friedman, M.D. henry.friedman@duke.edu Darell Bigner, M.D. darell.bigner@duke.edu John Sampson, M.D., Ph.D. john.sampson@duke.edu Dina Randazzo, D.O . dina.randazzo@duke.edu Elizabeth Reap, Ph.D. elizabeth.reap@duke.edu Peter Fecci, M.D., Ph.D. peter.fecci@duke.edu Hai Yan, M.D., Ph.D. hai.yan@duke.edu Brian Soher, Ph.D. brian.soher@duke.edu Statistician James E. Herndon II, Ph.D. james.herndon@duke.edu Lead Study Coordinator Sarah Woodring sarah.woodring@duke.edu Regulatory Coordinator Rachel Hesler, Ph.D. rachel.hesler@duke.edu Therapeutic Material Manufacture Manager Gary Archer, Ph.D. gary.archer@duke.edu Data Manager Eric Lipp eric.lipp@duke.edu Original version: 20140718 Amended version 1: 201508 31 for IND Submission Updated information in Figure 4 and in paragraph describing Figure 4 and inserted reference (Section 7.2.4 ); Added PT-PhI-II v05.22.12 Duke Cancer Institute Page 2 CONFIDENTIAL NCT# (Section 7.2.6 ); Inserted references (Section 9.2); Updated the study drug manufacturing company (Section 10.3); Corrected and updated reconstitution information of the study drug (Section 10.4.2); Updated references (Section 17); removed Td manufacturer name (Sections 9 and 10). Amended version2: 20151005 for FDA modifications 20151216 for IRB AMD002 Removed the saline injection to the contralateral leg (Section 10.4.1); Removed reference to femoral artery for administering vaccines (Sections 9.1 and 10.4.2); Added CBC and CMP blood draw time point in the table of scheduled assessments for leukapheresis screening with ionized calcium and pregnancy testing per Apheresis practice in footnote (Sect ion 12); Clarified “continues to do well” by defining criteria for vaccine therapy if pseudoprogressioin is suspected and clarified definition of progression vs pseudoprogression (Section 12.7.3); More clearly defined the definition of unacceptable toxicity (Sections 8, 9.1.1 , & 15.4.1); Updated the definition of SAE to match 21CFR312.23 (Section 13.2); Added the FDA for all adverse event reporting (Section 13.2.1); Corrected mis -numbering of inclusion criteria (Section 11.1 ); Added the exclusion of subjects unable to undergo MRI (Sections 11.2 & 12.8.2); Removed the word “transmural” from the 4 th exclusion criterion (Section 11.2); Removed ACD description of red top tubes (Section 12 ); Added an additional clinic visit with blood work to assess for delayed toxicity 1 month following last vaccine (Section 12). Amended version 3 20151216 for IRB AMD002 Removed exploratory objective comparison to historical controls (Section 8); Better described evaluable subjects (Sections 9.4 and 15.4.2); Updated location of paper documents (Section 0 ); Changed DLT to unacceptable toxicity (12.6.1 ); Removed statistical estimate (Section 15.4.2 ) Amended version 4 20160 201 for IRB AMD004 Added investigator s Dr. Fecci & Dr.