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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA204261 | U.S. NIH Grant/Contract | View source |
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Lack of enrollment
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| Name | Class |
|---|---|
| Parker Institute for Cancer Immunotherapy | OTHER |
| National Cancer Institute (NCI) | NIH |
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This is a pilot study to assess the safety and tolerability, as well as the immune response rate, of mDC3 vaccine in patients with colorectal cancer.
This is a pilot study to assess the safety and tolerability, as well as the immune response rate, of mDC3 vaccine in patients with colorectal cancer.
Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production approximately 1 week prior to vaccine infusion. Each study subject will receive cyclophosphamide 300mg/m^2 intravenously 3 to 4 days prior to the vaccine dose to deplete regulatory T cells. For each vaccine dose, all subjects will receive autologous dendritic cells pulsed with mutated peptides. On Day 1, the subject will receive the primer vaccine dose; this will be followed by one booster vaccine dose approximately 8 weeks later. Peripheral blood will be taken weekly, and a second apheresis procedure will be performed at the end of study to monitor the immune response to the vaccine. Information will be gathered from usual clinic visits for approximately 1 year following the End of Treatment Study Visit to evaluate for disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Experimental | All subjects will receive the vaccine and be followed per the schedule of procedures. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC vaccine | Biological | DC vaccine for colorectal cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 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. | 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. |
| Adverse Events Experienced by Subjects (i.e. Safety of DC Vaccine in Subjects With Surgically Resected Hypermutated CRC) | Number of subjects who experienced adverse events. Detailed adverse event data is presented in the AE section. | Through study completion (at 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of CD8+ Cells in Primary Tumor Tissue | Descriptive models | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim Reiss-Binder, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects will receive the vaccine and be followed per the schedule of procedures. DC vaccine: DC vaccine for colorectal cancer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 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. | 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. | Posted | Number | IFN-G producing cells / 5x10^5 cells | 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. |
Through study completion (at 12 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects | All subjects will receive the vaccine and be followed per the schedule of procedures. DC vaccine: DC vaccine for colorectal cancer |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regulatory Lead | University of Pennsylvania | 215-662-4484 | psom-ind-ide@pobox.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 11, 2021 | Jan 29, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 11, 2021 | Jan 29, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000706173 | lentiviral minigene vaccine of COVID-19 coronavirus |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | Subject 01, Antigen TBCC1D23 K632X | 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. |
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
| OG008 | 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. |
| OG009 | 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. |
| OG010 | 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. |
| OG011 | 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. |
| OG012 | 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. |
| OG013 | 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. |
| OG014 | 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. |
| OG015 | 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. |
| OG016 | 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. |
| OG017 | 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. |
| OG018 | 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. |
| OG019 | 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. |
| OG020 | 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. |
| OG021 | 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. |
| OG022 | 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. |
| OG023 | 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. |
|
|
| Primary | Adverse Events Experienced by Subjects (i.e. Safety of DC Vaccine in Subjects With Surgically Resected Hypermutated CRC) | Number of subjects who experienced adverse events. Detailed adverse event data is presented in the AE section. | The number of participants includes 1 subject who began the study but did not complete it. | Posted | Number | participants | Through study completion (at 12 months) |
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| Secondary | Percentage of CD8+ Cells in Primary Tumor Tissue | Descriptive models | 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. | Posted | 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. |
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| 0 |
| 4 |
| 0 |
| 4 |
| 4 |
| 4 |
| Chills | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Lymphocyte Count Decreased | Investigations | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |