DC Vaccine in Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT03730948|
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : September 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Biological: DC vaccine||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Mature Dendritic Cell Vaccination for Resected Hypermutated Colorectal Cancer|
|Actual Study Start Date :||March 12, 2019|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2021|
Experimental: All subjects
All subjects will receive the vaccine and be followed per the schedule of procedures.
Biological: DC vaccine
DC vaccine for colorectal cancer
- Changes in numbers of peptide-specific CD8+ T cells (post-vaccine immune response) [ Time Frame: 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. ]Numbers of peptide-specific CD8+ T cells will be measured by flow cytometric-based intracellular cytokine or tetramer staining
- Adverse events experienced by subjects (i.e. safety of DC vaccine in subjects with surgically resected hypermutated CRC) [ Time Frame: Through study completion (at 12 months) ]Review of adverse events experienced by subjects
- Percentage of CD8+ cells in primary tumor tissue [ Time Frame: 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. ]Descriptive models
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730948
|Contact: Emerging Medicine||855.216.0098||PennCancerTrials@emergingmed.com|
|Principal Investigator:||Kim Reiss-Binder, MD||University of Pennsylvania|