NCT07163403

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Fundacion Clinic per a la Recerca Biomédica · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

First in human, pilot, open-label, prospective, single-site, non-randomised study

Conditions

• Lynch Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Autologous 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.

Timeline

• Start date: 2025-09-04
• Primary completion: 2028-09-20
• Completion: 2028-09-20
• First posted: 2025-09-09
• Last updated: 2026-04-13

Locations

1 site across 1 country: Spain