Actively Recruiting
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
Led by Fundacion Clinic per a la Recerca Biomédica · Updated on 2026-04-13
20
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 pathogenic or likely pathogenic germline variants in MLH1, MSH2, or MSH6 mismatch repair genes
- No evidence of active or previous invasive cancer
- Endoscopically accessible colon
- Consent to standard surveillance with colonoscopy and biopsies every 1-2 years
- Age 18 years or older
- ECOG performance status of 0 or 1 (Karnofsky score 70% or higher)
- Adequate blood counts: hemoglobin ≥10 g/dL, 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/1.73m2
- Liver enzymes (AST/ALT) no more than 2 times upper limit of normal
- Total bilirubin ≤1.5 times upper limit of normal (higher allowed for Gilbert's disease with normal direct bilirubin)
- Written informed consent
- Women of child-bearing potential must have negative pregnancy test and agree to use effective contraception until one year after last immunization
You will not qualify if you...
- Carriers of pathogenic or likely pathogenic germline variant in PMS2
- Active or previous malignancy except non-melanoma skin cancer
- Cannot stop baseline medication including daily use of >100 mg aspirin, NSAIDs, or COX inhibitors during trial
- Serious uncontrolled or unstable medical or psychiatric disorders affecting 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 other immunosuppressive treatments
- Pregnant, breastfeeding, or planning pregnancy during first year after study
- Men planning to conceive during first year after study
- Use of other investigational agents within one month before inclusion
- Unable to avoid vaccinations during first 12 weeks of trial
- Inability to undergo leukapheresis (e.g., no peripheral venous access)
- Any condition interfering with study objectives as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Laura Burunat
Barcelona, Barcelona, Spain, 08036
Actively Recruiting
Research Team
L
Laura Burunat, Graduate
CONTACT
T
Thomas Walle, Doctor of Medicine
CONTACT
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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