Trial Outcomes & Findings for DC Vaccine in Colorectal Cancer (NCT NCT03730948)

Last Updated: 2024-05-24

Results Overview

Assessment of cellular immune activity may occur via the application of flow cytometry. Numbers of peptide-specific CD8+ T cells will be measured by flow cytometric-based intracellular cytokine or tetramer staining. Flow cytometric assays will include an examination of the influence of immunotherapy on the ability of subject T cells to exhibit phenotypic markers associated with cytolytic potential (e.g. IFN-y, IL-2, TNF-alpha, Granzyme B) after short-term stimulation by mutated peptide and p-HLA multimer staining. PBMC responses against a pool of known antigenic Cytomegalovirus, Epstein Barr Virus and Influenza epitopes will be evaluated in order to track general cellular immune competence during the study.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

4 participants

Primary outcome timeframe

Screening, Day 1, Day 43, Day 85. Also at following timepoints, which will vary by subject: 7-14 days after last vaccine; 30 days after last vaccine; every 3 months beginning 6 months since first vaccine until month 12.

Results posted on

2024-05-24

Participant Flow

Participant milestones

Participant milestones
Measure	All Subjects All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different. DC Vaccine #1: protocol-specified dose of 7.50x10\^6 - 1.50x10\^7 DC per peptide; minimum acceptable dose for infusion is 1.0x10\^6 DC per peptide. DC Vaccine #2 and #3: 1.0x10\^6 - 5.0x10\^6 DC per peptide; minimum acceptable dose for infusion is 1.0x10\^6 DC per peptide.
Overall Study STARTED	4
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DC Vaccine in Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=4 Participants All subjects will receive the vaccine and be followed per the schedule of procedures. DC vaccine: DC vaccine for colorectal cancer
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=99 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	3 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment United States	4 participants n=99 Participants

PRIMARY outcome

Timeframe: Screening, Day 1, Day 43, Day 85. Also at following timepoints, which will vary by subject: 7-14 days after last vaccine; 30 days after last vaccine; every 3 months beginning 6 months since first vaccine until month 12.

Population: Results are reported as IFN-G producing cells / 5x10\^5 cells, all CD3+ T cells. Neither subject was tested at 6 months, 9 months, or 12 months time points.

Outcome measures

Outcome measures
Measure	Subject 01, Antigen TBCC1D23 K632X n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 01, Antigen CDC7 L28X n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 01, Antigen MSH3 K381X n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 01, Antigen NKTR 613-614X n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 01, Antigen DDX51 P492L n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 01, Antigen APC A885X n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 01, Antigen TCERG1 R889X n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 01, Antigen MAP3K21 A767V n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 01, Antigen DAG1 W31R n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 01, Antigen ZC3H18 A886V n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 01, Antigen PRR11 K20X n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 01, Antigen MSH6 Q657H n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen DOCK3 T1850X n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen FAM214BA42X n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen FHDC1F100X n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen DOCK1E1616X n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen PLA2G6 S359L n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen POLG2K160E n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen LYSMD3 V111A n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen FARR459H n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen PDHXI190L n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen FNIP2 K575E n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen ARID1AG284X n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen ACVR2AK435X n=1 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.
Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) Screening	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells
Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) Day 1	0 IFN-G producing cells / 5x10^5 cells	1 IFN-G producing cells / 5x10^5 cells	33 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	27 IFN-G producing cells / 5x10^5 cells	36 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	1339 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	5 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	9 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	15 IFN-G producing cells / 5x10^5 cells	9 IFN-G producing cells / 5x10^5 cells
Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) Day 85 (week 12)	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	253 IFN-G producing cells / 5x10^5 cells	167 IFN-G producing cells / 5x10^5 cells	55 IFN-G producing cells / 5x10^5 cells	280 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	85 IFN-G producing cells / 5x10^5 cells	331 IFN-G producing cells / 5x10^5 cells	10 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	12 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	5 IFN-G producing cells / 5x10^5 cells	8 IFN-G producing cells / 5x10^5 cells	5 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	38 IFN-G producing cells / 5x10^5 cells	8 IFN-G producing cells / 5x10^5 cells	500 IFN-G producing cells / 5x10^5 cells	255 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	237 IFN-G producing cells / 5x10^5 cells
Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) 7-14 days after last vaccine (week 14)	53 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	286 IFN-G producing cells / 5x10^5 cells	13 IFN-G producing cells / 5x10^5 cells	306 IFN-G producing cells / 5x10^5 cells	352 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	9 IFN-G producing cells / 5x10^5 cells	432 IFN-G producing cells / 5x10^5 cells	10 IFN-G producing cells / 5x10^5 cells	3 IFN-G producing cells / 5x10^5 cells	5 IFN-G producing cells / 5x10^5 cells	4 IFN-G producing cells / 5x10^5 cells	19 IFN-G producing cells / 5x10^5 cells	10 IFN-G producing cells / 5x10^5 cells	5 IFN-G producing cells / 5x10^5 cells	2 IFN-G producing cells / 5x10^5 cells	2 IFN-G producing cells / 5x10^5 cells	29 IFN-G producing cells / 5x10^5 cells	414 IFN-G producing cells / 5x10^5 cells	491 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	80 IFN-G producing cells / 5x10^5 cells
Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) Day 43 (week 6)	201 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	234 IFN-G producing cells / 5x10^5 cells	312 IFN-G producing cells / 5x10^5 cells	65 IFN-G producing cells / 5x10^5 cells	240 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	650 IFN-G producing cells / 5x10^5 cells	5 IFN-G producing cells / 5x10^5 cells	17 IFN-G producing cells / 5x10^5 cells	5 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	43 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	34 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	289 IFN-G producing cells / 5x10^5 cells	75 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	618 IFN-G producing cells / 5x10^5 cells
Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) 30 days after last vaccine	325 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	1159 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	461 IFN-G producing cells / 5x10^5 cells	697 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	34 IFN-G producing cells / 5x10^5 cells	43 IFN-G producing cells / 5x10^5 cells	1250 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	1 IFN-G producing cells / 5x10^5 cells	0 IFN-G producing cells / 5x10^5 cells	789 IFN-G producing cells / 5x10^5 cells	453 IFN-G producing cells / 5x10^5 cells	20 IFN-G producing cells / 5x10^5 cells	2 IFN-G producing cells / 5x10^5 cells

PRIMARY outcome

Timeframe: Through study completion (at 12 months)

Population: The number of participants includes 1 subject who began the study but did not complete it.

Number of subjects who experienced adverse events. Detailed adverse event data is presented in the AE section.

Outcome measures

Outcome measures
Measure	Subject 01, Antigen TBCC1D23 K632X n=3 Participants All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 01, Antigen CDC7 L28X All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 01, Antigen MSH3 K381X All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 01, Antigen NKTR 613-614X All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 01, Antigen DDX51 P492L All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 01, Antigen APC A885X All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 01, Antigen TCERG1 R889X All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 01, Antigen MAP3K21 A767V All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 01, Antigen DAG1 W31R All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 01, Antigen ZC3H18 A886V All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 01, Antigen PRR11 K20X All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 01, Antigen MSH6 Q657H All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen DOCK3 T1850X All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen FAM214BA42X All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen FHDC1F100X All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen DOCK1E1616X All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen PLA2G6 S359L All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen POLG2K160E All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen LYSMD3 V111A All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen FARR459H All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen PDHXI190L All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen FNIP2 K575E All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen ARID1AG284X All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.	Subject 02, Antigen ACVR2AK435X All subjects will receive the DC vaccine for colorectal cancer and be followed per the schedule of procedures. Each subject's vaccine is created using a panel of subject-specific (unique) tumor neoantigen peptides. Therefore, antigens tested for each subject are different.
Adverse Events Experienced by Subjects (i.e. Safety of DC Vaccine in Subjects With Surgically Resected Hypermutated CRC)	3 participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: Per protocol, tissue samples will be used if obtained as part of standard of care procedures only. No samples were collected as part of standard of care procedures, therefore no analysis could be performed.

Descriptive models

Outcome measures

Outcome data not reported

Adverse Events

All Subjects

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Subjects n=4 participants at risk All subjects will receive the vaccine and be followed per the schedule of procedures. DC vaccine: DC vaccine for colorectal cancer
Gastrointestinal disorders Nausea	50.0% 2/4 • Number of events 2 • Through study completion (at 12 months)
General disorders Chills	50.0% 2/4 • Number of events 3 • Through study completion (at 12 months)
General disorders Fatigue	75.0% 3/4 • Number of events 3 • Through study completion (at 12 months)
General disorders Fever	25.0% 1/4 • Number of events 1 • Through study completion (at 12 months)
Investigations Lymphocyte Count Decreased	25.0% 1/4 • Number of events 1 • Through study completion (at 12 months)
Nervous system disorders Dizziness	25.0% 1/4 • Number of events 1 • Through study completion (at 12 months)
Nervous system disorders Dysgeusia	25.0% 1/4 • Number of events 1 • Through study completion (at 12 months)
Nervous system disorders Headache	25.0% 1/4 • Number of events 1 • Through study completion (at 12 months)
Respiratory, thoracic and mediastinal disorders Sore throat	25.0% 1/4 • Number of events 1 • Through study completion (at 12 months)
Vascular disorders Hypertension	25.0% 1/4 • Number of events 2 • Through study completion (at 12 months)

Additional Information

Regulatory Lead

University of Pennsylvania

Phone: 215-662-4484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place