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
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: 1. Individuals that are carriers of a pathogenic or likely pathogenic germline variant in one of the mismatch repair genes (MLH1, MSH2, MSH6). 2. Participants must have no evidence of active or previous invasive cancer. 3. Participants must have endoscopically accessible colon. 4. Participants must consent to follow the standard of care surveillance with colonoscopy and biopsies every 1-2 years. 5. Age ≥ 18 years 6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky ≥70%). 7. Haemoglobin ≥10 g/dL or haematocrit ≥30%; Leukocyte count ≥3.0x109/l; Platelet count ≥100x109/l; Absolute neutrophil count ≥1.5x109/l; Absolut lymphocyte count ≥0.8x109/l. 8. Creatinine clearance (calculated if measured is not available) ≥60mL/min/1.73m2. 9. Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\] ≤2 times the institutional upper limit of normal (ULN).