Lynch SyndromePhase 1DELAYNCT07163403
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
A Phase 1 study testing Autologous Tolerogenic Dendritic cells in people with Lynch Syndrome, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lynch Syndrome
- What is being tested?
- Autologous Tolerogenic Dendritic cells
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 4 Sep 2025to 20 Sep 2028
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%).
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- 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 dose. Highly effective contraceptive methods will include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence. * A woman will be considered of childbearing potential, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as 0 menses for 12 months without an alternative medical cause. A high follicle stimulating hormone level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single follicle stimulating hormone measurement is insufficient.
Who cannot join
- 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.
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Laura Burunat
Barcelona, Barcelona, 08036
Laura Burunat, Chemistry, 0034932275400 ext. 4198, burunat@recerca.clinic.cat
Francesc Balaguer, MDPhD
About this study
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.
Read the detailed description
First in human, pilot, open-label, prospective, single-site, non-randomised study
- Conditions
- Lynch Syndrome
- Being tested
- Autologous Tolerogenic Dendritic cells
- 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.
Autologous Tolerogenic Dendritic cellsBiological
Autologous peripheral blood differentiated and matured adult dendritic cells loaded with Frameshift-derived neopeptides (FSDN) (DC-DELAY). Eligible participants will receive six intradermal immunizations of DC-DELAY at week 0, 2, 4, 6, 8 and 10.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Patients with Lynch Syndrome which will recieve their own dendritic cells to evaluate safety and tolerability Receives: Biological: Autologous Tolerogenic Dendritic cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with grade 3-4 related adverse events for 12 months following the first immunization.
To evaluate the safety and tolerability of autologous peripheral blood differentiated and matured adult dendritic cells loaded with frameshift derived neopeptides (DC-DELAY) in LS carriers.
Measured: the first 12 month after the last inmunization
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.
To evaluate specific frameshift-derived neoantigens immunogenicity of DC-DELAY in LS carriers at week 12. NOTE: Immune response will be defined as T-cell reactivity to at least 1 out of 4 of the pools.
Measured: At week 12.
Secondary outcomes (7)
Proportion of participants with early immune response induced by DC-DELAY as measured inperipheral blood by ELISpot assay at week 6.
To evaluate the early-term specific frameshift-derived neoantigens immunogenicity of DC-DELAY in LS carriers at week 6.
Measured: Week 6
Proportion of participants with long term immune response induced by DC-DELAY as measured in peripheral blood by ELISpot assay at months 6, 12 and 24.
To evaluate the long-term specific frameshift-derived neoantigens immunogenicity of DC-DELAY in LS carriers at 6, 12 and 24 months.
Measured: Month 6, 12 and 24.
Proportion of participants with immune response induced by DC-DELAY as measured in the normal colonic mucosa at month 12.
To evaluate the specific frameshift-derived neoantigens immunogenicity of DC-DELAY in the normal colonic mucosa in LS carriers at month 12.
Measured: Month 12
Proportion of participants with mismatch repair deficient colorectal adenomas, advanced neoplasia and/or carcinoma throughout the study duration.
To evaluate the effect of DC-DELAY in LS carriers at week 12 on the burden of mismatch repair deficient colorectal neoplasia throughout the study duration.
Measured: Month 12 and month 36
Proportion of participants with LS-related carcinomas throughout the study duration (36 months).
To evaluate the effect of DC-DELAY immunization in LS carriers at week 12 on the burden of LSrelated carcinomas throughout the study duration.
Measured: Week 12 and month 36
Number and proportion of participants with related adverse events at 7 days after each DC-DELAY immunization.
To evaluate the safety and tolerability of DC-DELAY
Measured: 7 days after each iminization, week 0, week 2, week 4, week 6, uweek 8 and week 10.
Number and proportion of participants with grade 3-4 related adverse events throughout the study duration (36 months).
To evaluate the safety and tolerability of DC-DELAY throughout the study duration.
Measured: Through study completion, an average of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start4 Sep 2025
- Primary completion20 Sep 2028 (estimated)
- Study completion20 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lynch SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163403
- Sponsor's protocol ID
- 2025-521109-42-00
- Other IDs
- 2025
- Acronym
- DELAY
- Status last verified
- Feb 2026
- First submitted
- 30 Jul 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- DELAY / 2025-521109-42-00
- Conditions
- Lynch Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 20 Sep 2028 (estimated)
- Study completion
- 20 Sep 2028 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
First in human, pilot, open-label, prospective, single-site, non-randomised study
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Biological: Autologous Tolerogenic Dendritic cellsPatients with Lynch Syndrome which will recieve their own dendritic cells to evaluate safety and tolerability |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Tolerogenic Dendritic cellsAutologous peripheral blood differentiated and matured adult dendritic cells loaded with Frameshift-derived neopeptides (FSDN) (DC-DELAY). Eligible participants will receive six intradermal immunizations of DC-DELAY at week 0, 2, 4, 6, 8 and 10. | Biological | Single Arm |
Primary outcome
Proportion of participants with grade 3-4 related adverse events for 12 months following the first immunization.
Time frame: the first 12 month after the last inmunization
To evaluate the safety and tolerability of autologous peripheral blood differentiated and matured adult dendritic cells loaded with frameshift derived neopeptides (DC-DELAY) in LS carriers.
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.
Time frame: At week 12.
To evaluate specific frameshift-derived neoantigens immunogenicity of DC-DELAY in LS carriers at week 12. NOTE: Immune response will be defined as T-cell reactivity to at least 1 out of 4 of the pools.
7 secondary outcomes
Proportion of participants with early immune response induced by DC-DELAY as measured inperipheral blood by ELISpot assay at week 6.
Time frame: Week 6
Proportion of participants with long term immune response induced by DC-DELAY as measured in peripheral blood by ELISpot assay at months 6, 12 and 24.
Time frame: Month 6, 12 and 24.
Proportion of participants with immune response induced by DC-DELAY as measured in the normal colonic mucosa at month 12.
Time frame: Month 12
Proportion of participants with mismatch repair deficient colorectal adenomas, advanced neoplasia and/or carcinoma throughout the study duration.
Time frame: Month 12 and month 36
Proportion of participants with LS-related carcinomas throughout the study duration (36 months).
Time frame: Week 12 and month 36
Number and proportion of participants with related adverse events at 7 days after each DC-DELAY immunization.
Time frame: 7 days after each iminization, week 0, week 2, week 4, week 6, uweek 8 and week 10.
Number and proportion of participants with grade 3-4 related adverse events throughout the study duration (36 months).
Time frame: Through study completion, an average of 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Tolerogenic Dendritic cells in people with Lynch Syndrome, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
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 12 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 13 Apr 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 Spain. 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 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.
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?
Contact Laura Burunat, Graduate (0034 932275400 ext. 4198, burunat@recerca.clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with grade 3-4 related adverse events for 12 months following the first immunization. (time frame: the first 12 month after the last inmunization). 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?
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 13 Apr 2026; AzTrials last refreshed its copy on 1 Nov 2026.