RecruitingPhase 1NCT07163403

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


Sponsor

Fundacion Clinic per a la Recerca Biomédica

Enrollment

20 participants

Start Date

Sep 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing a cancer vaccine for people who carry Lynch syndrome — an inherited condition that significantly raises the risk of developing colon cancer and other cancers. The vaccine uses specially loaded immune cells (dendritic cells) to potentially train the immune system to prevent cancer from developing in the first place. **You may be eligible if...** - You are 18 or older - You carry a confirmed gene change (mutation) in a DNA repair gene (MLH1, MSH2, or MSH6) associated with Lynch syndrome - You do NOT currently have cancer and have no prior history of invasive cancer - You are willing to continue regular colonoscopy surveillance - Your blood counts and organ function meet study requirements **You may NOT be eligible if...** - You currently have or have had invasive cancer - You have autoimmune diseases or conditions requiring immune-suppressing drugs - You are pregnant or breastfeeding - You are not able to undergo colonoscopy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAutologous Tolerogenic Dendritic cells

Autologous peripheral blood differentiated and matured adult dendritic cells loaded with Frameshift-derived neopeptides (FSDN) (DC-DELAY). Eligible participants will receive six intradermal immunizations of DC-DELAY at week 0, 2, 4, 6, 8 and 10.


Locations(1)

Laura Burunat

Barcelona, Barcelona, Spain

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NCT07163403


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