First in Human Pilot Study to Assess the Safety and Efficacy of Dendritic Cells Loaded With Frameshift Derived Neopeptides for the Prevention of Cancer in of Lynch Syndrome Carriers

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundacion Clinic per a la Recerca Biomédica

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

Treatment groups

20 Participants
are divided into 1 treatment group