First in Human Pilot Study to Assess the Safety and Efficacy of Dendritic Cells Loaded With Frame… (NCT07163403) | Clinical Trial Compass
RecruitingPhase 1
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
Spain20 participantsStarted 2025-09-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Individuals that are carriers of a pathogenic or likely pathogenic germline variant in one of the mismatch repair genes (MLH1, MSH2, MSH6).
✓. Participants must have no evidence of active or previous invasive cancer.
✓. Participants must have endoscopically accessible colon.
✓. Participants must consent to follow the standard of care surveillance with colonoscopy and biopsies every 1-2 years.
✓. Age ≥ 18 years
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky ≥70%).
✓. Creatinine clearance (calculated if measured is not available) ≥60mL/min/1.73m2.
Exclusion criteria
✕. Individuals that are carriers of a pathogenic or likely pathogenic germline variant in PMS2.
✕. Individuals with active malignancy or previous malignancy (excluding non-melanoma skin cancer)
✕. Participants who cannot be removed from their baseline medication for the duration of the trial to administer the investigational treatment. This includes the daily use of \>100 mg aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase (COX) inhibitors.
What they're measuring
1
Proportion of participants with grade 3-4 related adverse events for 12 months following the first immunization.
Timeframe: the first 12 month after the last inmunization
2
Proportion of participants with specific frameshift-derived neoantigens immune response induced by DC-DELAY as measured in peripheral blood by enzyme-linked immune absorbent spot(ELISpot) assay at week 12.
✕. Any serious uncontrolled and /or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures.
✕. Patients with active systemic bacterial, viral or fungal infections or known to have human immunodeficiency virus (HIV) or to test positive for HIV antibody at screening.
✕. Positive hepatitis B surface antigen or hepatitis C antibody tests at screening.
✕. History of organ allograft or other history of immunodeficiency
✕. Individuals with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications.