17 On-Study Evaluation..................................................................................................... 18 Abbreviated Title: Personalized DC Vaccine Version Date: March 26, 2018 53.3.1 Within 7 Days Prior to the 1stVaccination (Day 0)............................................ ...... 18 3.3.2 Within 2 Days Prior to the 1stVaccination (Day 0)............................................ ...... 18 3.3.3 Within 2 Days Prior to Each Subsequent Vaccination (Days 14, 28 , and 42 (± 5 days)) 18 3.3.4 After Each Vaccination............................................................................................. 19 Post-Treatment Evaluation (Follow-Up) .......................... ............................................ 19 3.4.1 1stFollow-up Evaluation (Day 56 ± 5 days)......................... .................................... 19 3.4.2 Subsequent Follow-up Evaluations........................................................................... 19 Study Calendar.............................................................................................................. 21 Criteria for Removal from Protocol Therapy and Off-Study Criter ia .......................... 23 3.6.1 Criteria for Removal from Protocol Therapy..................... ....................................... 23 3.6.2 Off-Study Criteria ........................................ ............................................................. 23 3.6.3 Off Protocol Therapy an d Off-Study Procedure................... .................................... 23 4 CONCOMITANT MEDICATIONS/MEASURES.............................. ........................ 23 5 BIOSPECIMEN COLLECTION........................................ .......................................... 24 Samples Sent to Figg Lab ....................................... ...................................................... 24 Samples Sent to Surgery Bra nch Cell Production Facility ........ ................................... 24 Prior to Each Vaccination ...................................... ....................................................... 24 At Each Scheduled Follow-up Evaluation......................... ........................................... 24 Immunological Testing .......................................... ....................................................... 24 Sample Storage, Tracking and Disposition For Surgery Branch Cel l Production Facility ...................................................................................................................................... 25 Sample Storage, Tracking and Di sposition for Dr. Figg’s Lab .... ................................ 25 5.7.1 Sample Data Collection ............................................................................................ 25 5.7.2 Sample Storage and Destruction................................. .............................................. 26 6 DATA COLLECTION AND EVALUATION ............................................................. 26 Data Collection ................................................