NCT07412197

Preventive Dendritic Cell Vaccination for Lynch Syndrome

Targeting Cancer Neoantigens Through Multi-Epitope Vaccination for Tumour Prevention in Lynch Syndrome: a Phase I/II Clinical Trial.

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess safety, feasibility and immunogenicity of vaccination with neopeptide-loaded dendritic cells in Lynch Syndrome subjects who are known to be carrier of a germline MMR-gene mutation without signs of disease.

Detailed description

This is a single centre, single arm, phase I/II clinical trial to evaluate tumour prevention by targeting emergent cancer neoantigens through therapeutic multi-epitope vaccination in which LS subjects aged 35-75 who are confirmed to carry a germline MMR-gene mutation in MLH1, MSH2 or MSH6 without clinical signs of disease are participating for 36 months with corresponding 7 years follow-up.

Conditions

• Lynch Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	DC vaccination	Subjects in the DC vaccination arm will receive a maximum of 2 cycles each consisting of 3 DC injections intranodally (3-6x10\^6 DC)

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-12-01
• Completion: 2036-06-01
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: Netherlands