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Prevention study for Lynch Syndrome
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
ClinicalTrials.gov ID: NCT07163403
What this study is testing
What is Autologous Tolerogenic Dendritic cells?
Autologous Tolerogenic Dendritic cells is an investigational medicine, being studied as a potential treatment for lynch syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Any serious uncontrolled and /or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other...
- Patients with active systemic bacterial, viral or fungal infections or known to have human immunodeficiency virus (HIV) or to test positive for HIV...
- Positive hepatitis B surface antigen or hepatitis C antibody tests at screening.
See the full eligibility 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%).
- 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.
- Creatinine clearance (calculated if measured is not available) ≥60mL/min/1.73m2.
- 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).
- Total bilirubin ≤ 1.5 the ULN; participants with Gilbert's disease may be enrolled with higher total bilirubin if their direct bilirubin is ≤1.5 times the ULN.
- Written informed consent.
- Women of child-bearing potential\ must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods until one year following the las immunization...
- 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...
- 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...
- 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.
- Pregnant or breastfeeding or planning to become pregnant during the first year after the completion of the study treatment.
- Men attempting or planning to conceive children during the first year after the completion of the study treatment.
- Participants cannot receive any other investigational agents in the last month before its inclusion.
- Participants unable to refrain to receive any type of vaccination during the first 12 weeks of the trial.
- Impossibility to proceed to the leukapheresis (e.g. absence of peripheral venous access).
- Any other problem that according to the investigator could interfere with the evaluation of the objectives
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.