l. Tests/procedures used to evaluate the subject’s eligibility to participate must be performed prior to physician -investigator confirmation of eligibility and within 28 days prior to physici an-investigator confirmation of eligibility unless otherwise specified. Tests/procedures performed screening/enrollment which also fall within the 14 day window required for Pre -Treatment evaluations may be used to fulfill this additional study requirement and do not need to be repeated unless clinically indicated. DC Vaccine for Colorectal Cancer Page 22 of 34 Version 7.11-11-2021 CONFIDENTIAL This protocol is the property of the University of Pennsylvania. Do not disclose or use except as authorized in writing by the study spons or. 11.0 EARLY WITHDRAWAL OF SUBJECTS Subjects who enroll but who do not receive the DC Vaccine #1 will be prematurely discontinued from the study, including all study procedures/follow -up activities (with the exception of monitoring of ongoing adverse events felt to be related to research procedures), and will be replaced. Reasons for premature study discontinuation prior to receipt of the DC Vaccine #1 may include, but are not limited to the following: • The judgment of the principal investigator that the subject is too ill to continue if this occurs prior to the vaccine dose. • Technical difficulties are encountered in the manufacturing process that preclude generation of a vaccine dose that meets all Quality Control criteria. • If a subject develops a condition that precludes treatment after enrollment but before administration of the vaccine dose. This will be done at the judgment of the PI, and could include for example, disease recurrence requiring alternative treatment, or a serious adverse event. • Subject withdraws consent • Termination of the study Subjects who receive DC Vaccine #1 may be discontinued from receiving additional study treatment/primary follow -up for any of the following reasons: • Subject withdraws consent . • The PI decides to discontinue the study treatment (i.e. for non- compliance with the protocol or disease recurrence requiring urgent therapeutic intervention). • Subjects who develop DLT (as defined in Section 9.1 ). • Subjects who develop an allergic reaction to the dendritic cell vaccine (mDC3/8 vaccines ). • Pregnancy • Termination of the study All s ubjects who complete/ prematurely discontinue from the study after receipt of at least one DC vaccine infusion will be asked to complete an End of Study Treatment visit no sooner than 30 days after the ir last mDC3/8 Vaccine. Following the End of Study Treatment visit, subjects will continue to be followed for safety and the collection of immune monitoring samples for up to 1 year post -DC Vaccine #1. The first Post-DC Vaccine Surveillance Visit will occur approximately 6 months after DC Vaccine #1. Immune monitoring samples will continue to be collected every 3 months during Post -DC Vaccine Surveillance Visit until the End of Study Visit. Subjects may be discontinued from Post- DC Vaccine Surveillance Follow -up for the following reasons: • Subject withdraws consent • Death • Investigator Discretion - Subjects will be asked to complete an End of Study Visit. • Termination of the study • Completion of Post- DC Vaccine Surveillance (12 months post- DC Vaccine #1) - Subjects will be asked to complete an End of Study Visit. DC Vaccine for Colorectal Cancer Page 23 of 34 Version 7.11-11-2021 CONFIDENTIAL This protocol is the property of the University of Pennsylvania. Do not disclose or use except as authorized in writing by the study spons or. 12.0 SAFETY AND ADVERSE EVENTS 12.1 Definitions Adverse Event An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Intercurrent illnesses or injuries should be regarded as adverse events. Serious Adverse Event Adverse events are classified as serious or non -serious. A serious adverse event is any AE or PDAE that is: • fatal • life-threatening • requires or prolongs hospital stay • leads to a persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions • a congenital anomaly or birth defect • an important medical event Note that hospitalizations that meet the following criteria should not be reported as serious adverse events: • Routine treatment or m onitoring of the studied indication, not associated with any deterioration in condition, such as preplanned study visits and preplanned hospitalizations for study procedures or treatment administration • Elective or pre -planned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since signing the informed consent • Social reasons and respite care in the absence of any deterioration in the subject’s general condition Note : Treatment on an emergency outpatient basis that does not result in hospital admission and involves an event not fulfilling any of the definitions of a SAE given above is not a serious adverse event. Important medical events are those that may not be immediately life threatening, but are clearly of major clinical significance. They may jeopardize the subject , and may require intervention to prevent one of the other serious outcomes noted above. For example, drug overdose or abuse, a seizure that did not result- in patient hospitalization, or intensive treatment of bronchospasm in an emergency department would typically be considered serious. All adverse events that do not meet any of the criteria for serious should be regarded as non- serious adverse event s. Unanticipated Adverse Device Effect (UADE) Unanticipated adverse device effect means any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. DC Vaccine for Colorectal Cancer Page 24 of 34 Version 7.11-11-2021 CONFIDENTIAL This protocol is the property of the University of Pennsylvania. Do not disclose or use except as authorized in writing by the study spons or. Unexpected Adverse Events An adverse event is considered unexpected if the event , and the severity (grade) and/or frequency of the event, is not described in the investigator brochure or protocol. Please refer to the investigator brochure for additional detail related to severity and/or frequency of a particular event. Related Adverse Events An adverse event is considered related to participation in the research if there is a reasonable possibility that an event was caused by an investigational product, intervention, or research- required procedures. For the purposes of this study, "reasonable possibility" means there is evidence to suggest a causal relationship. The relationship of the event to the study will be classified as possibly related, probably related, and definitely related. • Possibly Related: There is some evidence to suggest a causal relationship; however, other factors may have contributed to the event. • Probably Related: There is evidence to suggest a causal relationship, and the influence of other factors is unlikely. • Definitely Related: There is clear evidence to suggest a causal relationship, and other possible contributing factors can be ruled out. Protocol defined adverse events (PDAEs) During Post -DC Vaccine Surveillance, only protocol‐defined adverse events (PDAEs) will be collected and reported. Protocol -defined adverse events that are determined to be serious as defined above will be considered protocol -defined serious adverse events (PDSAEs) and also require expedited reporting to the Sponsor per Section 12.3. The PDAEs are as follows: • Any adverse events ongoing at the End of Study Treatment. These events must be followed until resolution or End of Study. • Any adverse events determined to be possibly related to the investigational product. Adverse Event Reporting Period For this study, collection of AEs will begin at the time of the first apheresis procedure (Apheresis #1) and continue until subject discontinuation or the End of Study Visit. Preexisting Condition /General Physical Examination Findings A preexisting condition is one that is present at the start of the Adverse Event Reporting Period. All clinically significant abnormalities should be recorded as a preexisting condition on the medical history eCRF. During the course of the study, a preexisting condition should be recorded as an adverse event if the frequency, intensity, or the character of the condition worsens. Preexisting conditions that improve should also be recorded appropriately. Abnormal Laboratory Values A clinical laboratory abnormality should be documented as an adverse event if any one of the following conditions is met: • The laboratory abnormality is not otherwise refuted by a repeat test to confirm the abnormality • The abnormality suggests a disease and/or organ toxicity • The abnormality is of a degree that requires active management; e.g. change of dose, discontinuation of the drug, more frequent follow- up assessments, further diagnostic DC Vaccine for Colorectal Cancer Page 25 of 34 Version 7.11-11-2021 CONFIDENTIAL This protocol is the property of the University of Pennsylvania. Do not disclose or use except as authorized in writing by the study spons or.