Actively Recruiting
First in Human Pilot Study to Assess Safety and Efficacy of Dendritic Cells Loaded With Frameshift Derived Neopeptides for Cancer Prevention in Lynch Syndrome Carriers
Led by Fundacion Clinic per a la Recerca Biomédica · Updated on 2026-04-13
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and immune response of a new treatment using a patient's own dendritic cells loaded with frameshift-derived neopeptides to prevent cancer in people with Lynch Syndrome. This pilot, open-label study is the first time this treatment is tested in humans and is not randomized. It is sponsored by Fundacion Clinic per a la Recerca Biomédica and focuses on individuals who carry genetic variants linked to Lynch Syndrome but have no active or previous invasive cancer. Eligible participants will receive six doses of their own specially prepared dendritic cells (called DC-DELAY) through intradermal immunizations at weeks 0, 2, 4, 6, 8, and 10. This treatment aims to stimulate the immune system to recognize cancer-related proteins. The study will monitor participants for up to three years to track immune responses and any signs of cancer development. Participants will be closely monitored through blood tests, colonoscopies, and biopsies to assess safety and immune response at various time points including weeks 6 and 12, and months 6, 12, 24, and 36. Researchers will look for side effects, immune reactions, and the presence of precancerous or cancerous lesions. Participants must continue regular standard care surveillance with colonoscopies every 1 to 2 years. The total study duration involves follow-ups for up to three years after the last immunization.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Carriers of a pathogenic or likely pathogenic germline variant in MLH1, MSH2, or MSH6 mismatch repair genes
- No evidence of active or previous invasive cancer
- Colon accessible for endoscopic examination
- Agree to standard surveillance with colonoscopy and biopsies every 1-2 years
- Age 18 years or older
- ECOG performance status 0 or 1 (Karnofsky score 70% or higher)
- Adequate blood counts: hemoglobin ≥10 g/dL or hematocrit ≥30%; leukocytes ≥3.0x10^9/L; platelets ≥100x10^9/L; neutrophils ≥1.5x10^9/L; lymphocytes ≥0.8x10^9/L
- Creatinine clearance ≥60 mL/min/1.73 m²
- Liver function tests: AST and ALT ≤2 times upper normal limit
- Total bilirubin ≤1.5 times upper normal limit (higher allowed with Gilbert's disease if direct bilirubin ≤1.5x ULN)
- Written informed consent
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception until one year after last immunization
You will not qualify if you...
- Carriers of a pathogenic or likely pathogenic germline variant in PMS2 gene
- Active or previous malignancy (except non-melanoma skin cancer)
- Inability to stop baseline medications like >100 mg aspirin, NSAIDs, or COX inhibitors during trial
- Serious uncontrolled or unstable medical or psychiatric disorders interfering with safety or compliance
- Active systemic bacterial, viral, or fungal infections; HIV positive
- Positive hepatitis B surface antigen or hepatitis C antibody
- History of organ transplant or immunodeficiency
- Need for systemic corticosteroids or immunosuppressive medications
- Pregnant, breastfeeding, or planning pregnancy within one year after treatment
- Men planning to conceive within one year after treatment
- Use of other investigational agents within one month before study
- Inability to avoid vaccinations during first 12 weeks
- Inability to undergo leukapheresis (e.g., no peripheral venous access)
- Any other condition that may interfere with study evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 10 weeks
Participants receive six intradermal immunizations of their own dendritic cells loaded with frameshift-derived neopeptides to evaluate safety and immune response.
6 visits for immunizations at weeks 0, 2, 4, 6, 8, and 10 (in-person)
Duration - Up to 36 months
Participants are monitored for safety and immune response for up to 36 months after the last immunization.
Visits at week 12, months 6, 12, and 24 for immune response assessments and ongoing safety monitoring
Trial Site Locations
Total: 1 location
1
Laura Burunat
Barcelona, Barcelona, Spain, 08036
Actively Recruiting
Research Team
L
Laura Burunat, Graduate
T
Thomas Walle, Doctor of Medicine
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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