Could a vaccine stop cancer before it starts in lynch syndrome?

NCT ID NCT07412197

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This early-phase trial tests a personalized vaccine made from a person's own immune cells (dendritic cells) loaded with cancer-specific markers. The goal is to train the immune system to recognize and destroy precancerous cells in people with Lynch syndrome, who have a high risk of several cancers. The study will enroll 13 participants without active cancer to see if the vaccine is safe, feasible to produce, and triggers an immune response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dendritic cell vaccine loaded with neopeptides
What this could lead to
If successful, this could lead to a vaccine that prevents cancer in people with Lynch syndrome, reducing their lifetime cancer risk.
What could go wrong
This is a very early phase 1/2 trial with only 13 participants, so it is primarily testing safety and feasibility. The vaccine may not trigger a strong enough immune response or prevent tumors long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 2036

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Colorectal Neoplasms, Hereditary Nonpolyposis Lynch syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Radboudumc

    Nijmegen, Netherlands

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