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This research study is designed to evaluate the effects of a dendritic cell (kind of white blood cell) vaccine for pancreatic cancer.
This is a single arm open label trial that will assess the safety and tolerability of mature dendritic cell (mDC3/8) vaccine (primer and booster) in subjects with resected pancreatic adenocarcinoma.
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 mutant KRAS peptides corresponding to the subject's specific tumor mutation and human leukocyte antigen type. 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 recurrence.
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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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mDC3/8-KRAS Vaccine | Drug | Mature dendritic cell (mDC3/8) vaccine (primer and booster) in subjects with resected pancreatic adenocarcinoma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and side effects of vaccine per CTCAE 4.0 | At time of consent through 30 days after the subject's last DC vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Immune response measuring increased numbers of peptide specific T cells as calculated by the peptide-MHC multimer assay. | Day 1 through week 12 | |
| Disease Free Survival | 30 days following second vaccine through study completion approximately 12 months after the first DC vaccine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark O'Hara, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39287991 | Derived | Bear AS, Nadler RB, O'Hara MH, Stanton KL, Xu C, Saporito RJ, Rech AJ, Baroja ML, Blanchard T, Elliott MH, Ford MJ, Jones R, Patel S, Brennan A, O'Neil Z, Powell DJ Jr, Vonderheide RH, Linette GP, Carreno BM. Natural TCRs targeting KRASG12V display fine specificity and sensitivity to human solid tumors. J Clin Invest. 2024 Sep 17;134(21):e175790. doi: 10.1172/JCI175790. |
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