About this trial
Tha aim of this clinical trial is to evaluate safety and tolerability of autologous peripheral blood differentiated and matured adult dendritic cells. Immunogenicity of the prduct(DC-DELAY) will be evaluated also.
Eligibility criteria
Qualifiers
Individuals that are carriers of a pathogenic or likely pathogenic germline variant in one of the mismatch repair genes (MLH1, MSH2, MSH6).
Participants must have no evidence of active or previous invasive cancer.
Participants must have endoscopically accessible colon.
Participants must consent to follow the standard of care surveillance with colonoscopy and biopsies every 1-2 years.
Disqualifiers
Individuals that are carriers of a pathogenic or likely pathogenic germline variant in PMS2.
Individuals with active malignancy or previous malignancy (excluding non-melanoma skin cancer)
Participants who cannot be removed from their baseline medication for the duration of the trial to administer the investigational treatment. This includes the daily use of >100 mg aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase (COX) inhibitors.
Any serious uncontrolled and /or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures.
Trial design
Treatments tested in this trial
- Autologous Tolerogenic Dendritic cells