OncoMatch/Clinical Trials/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
Is NCT07163403 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Autologous Tolerogenic Dendritic cells for lynch syndrome.
Treatment: Autologous Tolerogenic Dendritic cells — 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.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: MLH1 pathogenic or likely pathogenic germline variant
carriers of a pathogenic or likely pathogenic germline variant in one of the mismatch repair genes (MLH1, MSH2, MSH6)
Required: MSH2 pathogenic or likely pathogenic germline variant
carriers of a pathogenic or likely pathogenic germline variant in one of the mismatch repair genes (MLH1, MSH2, MSH6)
Required: MSH6 pathogenic or likely pathogenic germline variant
carriers of a pathogenic or likely pathogenic germline variant in one of the mismatch repair genes (MLH1, MSH2, MSH6)
Excluded: PMS2 pathogenic or likely pathogenic germline variant
Individuals that are carriers of a pathogenic or likely pathogenic germline variant in PMS2
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
Haemoglobin ≥10 g/dL or haematocrit ≥30%; Leukocyte count ≥3.0x10^9/l; Platelet count ≥100x10^9/l; Absolute neutrophil count ≥1.5x10^9/l; Absolute lymphocyte count ≥0.8x10^9/l
Kidney function
Creatinine clearance ≥60 mL/min/1.73m2
Liver function
AST (SGOT)/ALT (SGPT) ≤2x ULN; total bilirubin ≤1.5x ULN (Gilbert's disease exception: direct bilirubin ≤1.5x ULN)
Haemoglobin ≥10 g/dL or haematocrit ≥30%; Leukocyte count ≥3.0x10^9/l; Platelet count ≥100x10^9/l; Absolute neutrophil count ≥1.5x10^9/l; Absolute lymphocyte count ≥0.8x10^9/l. Creatinine clearance ≥60mL/min/1.73m2. AST (SGOT)/ALT (SGPT) ≤2x ULN. Total bilirubin ≤ 1.5x ULN (Gilbert's disease exception: direct bilirubin ≤1.5x ULN).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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