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Preventive Dendritic Cell Vaccination for Lynch Syndrome

ConditionLynch Syndrome
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age35-75
SponsorRadboud University Medical Center

About this trial

The aim of this study is to assess safety, immunogenicity and feasibility of vaccination with neopeptide-loaded dendritic cells in Lynch Syndrome subjects who are known to be carrier of a germline MMR-gene mutation without signs of disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

a confirmed gPV in MLH1 or MSH2 and without a prior history of MMR-D cancer.

a confirmed gPV in MSH6, whether or not they have a history of MMR-D cancer. MSH6 subjects with a history of MMR-D cancer have to be cancer-free for more than 1 year.

previous surgical treatment may include any resection up to and including hemicolectomy; subjects who have undergone (sub)total colectomy are excluded due to the substantially reduced risk of cancer occurrence.

aged between 35 and 75 for subjects with gPV in MLH1 and MSH2; and aged between 40 and 75 for subjects with gPV in MSH6.

Disqualifiers

Individuals with a history of malignancy in the past. Allowed malignancies are adequately treated basal cell carcinoma and squamous cell carcinoma of the skin, carcinoma in situ (e.g., DCIS/LCIS/cervical CIS), papillary thyroid carcinoma, and low-risk prostate carcinoma; all locally resected with negative surgical margins and not treated with systemic therapy.

Organ allografts.

Known allergy to shellfish.

Inability to understand and communicate in Dutch.

Trial design

Design model

Single group

Treatments tested in this trial

  • DC vaccination

    Biological/Vaccine

    Subjects in the DC vaccination arm will receive a maximum of 2 cycles each consisting of 3 DC injections intranodally (3-7x10\^6 DC)

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: DC vaccinationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with Treatment-Related adverse events as assessed by CTCAE v5.0 (Safety)

Time frame
2 years
2

To assess whether neoantigen-specific T cells are induced by the DC vaccine (immunogenicity).

Immunogenicity will be assessed by the percentage of participants showing a neo-antigen-specific T cell response, defined by the expansion of T cells that recognize tumor antigens and demonstrate effector functions. Non-responders are those with no T cell expansion or insufficient immune activity.

Time frame
4 years

Secondary outcomes

1

Disease-free survival

To evaluate whether LS subjects who develop a T cell response to a frameshift-derived neoantigen included in the vaccine have an improved DFS; defined as the time from the 1st vaccination until development of an MMR-D colorectal adenoma, any LS-associated carcinoma in situ, or any LS-associated carcinoma, or until follow up ends, whichever occurs first.

Time frame
10 years
2

Quality of Life Questionnaires

To evaluate whether LS subjects who develop a T cell response to a frameshift-derived neoantigen included in the vaccine have an improved QoL; defined as patient's self-perceived physical, psychological and social well-being in relation to their health status, assessed using questionnaires.

Time frame
baseline, week 3, week 28, week 50, month 36, month 60, month 84, month 108
3

Number of participants successfully enrolled for manufacturing autologous DC product with sufficient yield for at least one injection intranodally (IN) for treatment purposes and one intradermally (ID) for diagnostic purposes(Feasibility)

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Radboud University Medical Center

Lead sponsor

Dutch Cancer Society

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: