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Pilot Study of Mature Dendritic Cell Vaccination for Resected Hypermutated 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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Start Date
March 12, 2019
Primary Completion Date
February 22, 2022
Completion Date
December 1, 2022
Last Updated
May 24, 2024
4
ACTUAL participants
DC vaccine
BIOLOGICAL
Lead Sponsor
University of Pennsylvania
Collaborators
NCT06696768
NCT04704661
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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