AzTrials
AzTrials

Lynch SyndromePhase 1/2PREVENT-LynchNCT07412197

Preventive Dendritic Cell Vaccination for Lynch Syndrome

A Phase 1/2 study testing DC vaccination in people with Lynch Syndrome, run by Radboud University Medical Center at 1 site in Netherlands.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 35 to 75 years
Conditions the study is for
Lynch Syndrome
What is being tested?
DC vaccination
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteNetherlands
Study dates
Oct 2026to Jun 2036
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Lynch syndrome subjects without clinical signs of disease.
  • Lynch syndrome subjects with a prior history of colorectal premalignancies with at least 1 adenoma sample archived.
Show all 20Show fewer
  • Lynch syndrome subjects without prior treatment for LS-associated cancer, except for MSH6 subjects who are >1 year disease-free and whose prior surgical treatment did not include subtotal colectomy.
  • Routine surveillance colonoscopy must be performed within 16 weeks prior to start of study, to exclude (pre)malignancy.
  • HLA-A02.01 genotype
  • Adequate hematologic, renal, and liver function as defined by laboratory values: WBC >3.0^109/l, lymphocytes >0.8^109/l, platelets >100^109/l, haemoglobin >7,0 mmol/l (9.0 g/dl), estimated glomerular filtration rate > 45 ml/min/1.73m2, AST/ALT <3 x ULN, serum crea¬tinine <150 µmol/l, serum bilirubin <1.5 x ULN (exception: Gilbert's syndrome is permitted).
  • WHO performance status of 0 or 1
  • No concomitant use of immunosuppressive drugs orally or intravenously. Topical and intranasal steroids are permitted.
  • No uncontrolled infectious disease, i.e., negative testing for HIV, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and syphilis (Treponema Pallidum Hemagglutination Assay (TPHA)).
  • No autoimmune disease such as, but not limited to, inflammatory bowel disease, multiple sclerosis, and lupus. Subjects with type 1 diabetes mellitus, hypothyroidism after autoimmune thyroiditis and skin disorders are not excluded.
  • No serious (bleeding and clotting) condition that may interfere with safe leukapheresis.
  • No pregnant or lactating women. hCG tests will be performed regularly during the trial to confirm absence of pregnancy.
  • No Women Of Child-Bearing Potential (WOCBP) or male partners of WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 8 weeks after the last administration of the treatment. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea > 12 consecutive months].
  • Subjects must have absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions must be discussed with the subject before registration in the trial.
  • Expected adequacy of follow-up.
  • Written informed consent.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Netherlands1 site

  • Radboudumc

    Nijmegen

    Jolanda de Vries, Prof. dr.

Other trials in Netherlands

About this study

Official title: Targeting Cancer Neoantigens Through Multi-Epitope Vaccination for Tumour Prevention in Lynch Syndrome: a Phase I/II Clinical 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.

Read the detailed description

A single-centre, single-arm phase I/II clinical trial evaluating the safety and immunogeniticy of therapeutic multi-epitope vaccination targeting emergent cancer neoantigens for tumour prevention. The study will include LS subjects aged 35-75 who carry a confirmed germline MMR gene mutation (MLH1, MSH2, or MSH6) and have no clinical signs of disease. Participants will be followed for 36 months, with an additional 7 years of follow-up

Conditions
Lynch Syndrome
Being tested
DC vaccination
Keywords
Dendritic cells, Cancer vaccine, Hereditary cancer, Lynch Syndrome, Prevention, Neoantigens
Medical subject headings
Colorectal Neoplasms, Hereditary Nonpolyposis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DC vaccinationBiological

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

Study groups in NCT07412197
Study groupRoleWhat they receive
DC vaccinationExperimentalSubjects in the DC vaccination arm will receive a maximum of 2 cycles each consisting of 3 DC injections intranodally
Receives: Biological: DC vaccination

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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.

    Measured: 4 years

Secondary outcomes (3)

  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.

    Measured: 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.

    Measured: 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)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionDec 2029 (estimated)
  4. Study completionJun 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07412197
Sponsor's protocol ID
EU CT 2025-524046-10-00
Acronym
PREVENT-Lynch
Status last verified
Dec 2025
First submitted
5 Feb 2026
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DC vaccination in people with Lynch Syndrome, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Treatment-Related adverse events as assessed by CTCAE v5.0 (Safety) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07412197.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in