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Esophageal CancerPhase 1/2IL15-TransDCNCT05964361

First-in-human Interleukin-15-transpresenting Wilms' Tumor Protein 1-targeting Autologous Dendritic Cell Vaccination in Cancer Patients

A Phase 1/2 study testing IL15-transpresenting WT1-targeted Dendritic Cell Vaccine in people with Esophageal Cancer and Pancreas Cancer, run by University Hospital, Antwerp at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The goal of this clinical trial is to investigate a new type of dendritic cell vaccine in patients with refractory or advanced solid tumors of the esophagus, liver, pancreas and ovaries. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer, Pancreas Cancer, Ovarian Cancer
What is being tested?
IL15-transpresenting WT1-targeted Dendritic Cell Vaccine
How many people
10 participants
Where
1 siteBelgium
Study dates
6 Dec 2023to 22 Sep 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • Signed informed consent (i.e. date of study entry (T0))
  • Age ≥ 18 years at the time of signing informed consent
  • Diagnosis with a histologically or cytologically confirmed solid tumor of the pancreas, esophagus, liver or ovaries that is advanced, recurrent or progressing after at least first-line anti-cancer treatment, or for which no alternative standard therapy is available due to intolerance to or refusal of standard-of-care treatment.
  • Adequate hematological blood values following previous anti-cancer treatments, as judged by the Principal Investigator
  • All treatment-related toxicities must have resolved to CTCAE grade ≤ 2 or must be stable and well controlled with minimal, local or non-invasive intervention, as judged by the Principal Investigator
  • Reasonable life expectancy of at least 3 months, as estimated by the Principal Investigator
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  • At least 1 measurable or evaluable lesion as defined by the latest version of Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) guidelines
  • Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained at the time of screening:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1500/µL) without granulocyte colony-stimulating factor support
  • Lymphocyte count ≥ 0.5 x 109/L (500/µL)
  • Platelet count ≥ 100 x 109/L (100,000/µL) without transfusion
  • Hemoglobin ≥ 90 g/L (9 g/dL) (Patients may be transfused to meet this criterion)
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 x upper limit of normal (ULN), with the following exceptions:
  • Patients with documented liver metastases: AST and ALT ≤ 5 x ULN
  • Patients with documented liver or bone metastases: ALP ≤ 5 x ULN
  • Total bilirubin ≤ 2 x ULN with the following exception:
  • Patients with known Gilbert disease: total bilirubin ≤ 3 x ULN
  • Creatinine ≤ 1.5 x ULN
  • Albumin ≥ 25 g/L (2.5 g/dL)
  • Phosphorus ≥ 0.78 mmol/L
  • World Health Organization (WHO) performance status 0-2
  • Willing or able to comply with the protocol, as judged by the Principal Investigator
  • Women of child bearing potential must have a negative serum or urine pregnancy test at the time of screening. Women of child bearing potential and men must agree to use effective contraception before, during and for at least hundred days after the last study treatment administration.

Who cannot join

  • Use of any investigational agent within 4 weeks before the planned day of leukapheresis
  • Corticosteroid treatment within 1 week before leukapheresis, unless the Principal Investigator rationalizes otherwise
  • Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, anti-phospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:
  • Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study.
  • Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
  • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
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  • Rash must cover < 10% of body surface area
  • Disease is well controlled at baseline and requires only low-potency topical corticosteroids
  • No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months
  • Non-treated brain or meningeal mestases, or priorly treated brain or meningeal metastases with magnetic resonance imaging (MRI) evidence of progression in the last 8 weeks
  • Pregnant or breastfeeding. Female subjects who are breastfeeding should discontinue nursing prior to the first dose of study treatment and until at least hundred days after the last study treatment administration
  • Any other condition, either physical or psychological, or reasonable suspicion thereof on clinical or special investigation, which contraindicates the use of the vaccine, or may negatively affect patient compliance, or may place the patient at higher risk of potential treatment complications.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Antwerp University Hospital

    Edegem, 2650

Other trials in Belgium

About this study

The goal of this clinical trial is to investigate a new type of dendritic cell vaccine in patients with refractory or advanced solid tumors of the esophagus, liver, pancreas and ovaries. The main questions it aims to answer are:

  • is it feasible to produce and administer these dendritic cell vaccines?
  • is treatment with these dendritic cell vaccines safe?

Participants will first need to undergo a leukapheresis procedure to collect the cellular starting material for the dendritic cell vaccine production. The treatment consists of 6 vaccines, administered at biweekly intervals. Participants will be followed-up until 90 days after the last vaccine.

Read the detailed description

The investigational medicinal product concerns dendritic cells that were engineered to target the tumor antigen Wilms' Tumor-1 (WT1) and in addition transpresent the cytokine IL15 on their cell surface. By inclusion of the IL15-transpresentation mechanism, the intention is to render the dendritic cell more immunogenic (i.e. they have a higher capacity to stimulate the immune system to recognize and attack WT1-expressing cancer cells).

Being tested
IL15-transpresenting WT1-targeted Dendritic Cell Vaccine
Medical subject headings
Esophageal Neoplasms, Pancreatic Neoplasms, Ovarian Neoplasms, Liver Neoplasms

What participants receive

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

  • IL15-transpresenting WT1-targeted Dendritic Cell VaccineBiological

    Also called IL15/IL15Ra/WT1 DC vaccine, IL15-transpresenting WT1-targeting DC vaccine

    IL15/IL15Ra/WT1 DC vaccines (8-10 x 10^6 cells in 500 μL saline solution with 5% human albumin) will be administered through intradermal injection at 5 sites (100 μL/site) in the ventromedial region of the upper arm (5-10 cm from the axillary lymph nodes). Injection sites will alternate between left and right arms. WT1/DC vaccines are administered every 2 weeks (+- 3 days) for a total of 6 administrations.

What is being measured

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

  1. Feasibilty of leukapheresis

    Proportion of patients in the intention-to-treat population that had a successful leukapheresis.

    Measured: Upon completion of leukapheresis, on average 4 weeks after inclusion (baseline)

  2. Feasibility of IL15/IL15Ra/WT1 DC vaccine production

    Proportion of patients in the intention-to-treat population that had successful vaccine production (i.e. production of at least 6 IL-15-transpresenting WT1-targeting DC vaccines meeting all quality control measurements).

    Measured: Upon completion of vaccine production and quality testing (i.e. from leukapheresis until 4 weeks after), on average 8 weeks after inclusion (baseline)

  3. Feasibility of study treatment scheme

    Proportion of patients in the intention-to-treat population who complete the study treatment schedule of 6 IL-15-transpresenting WT1-targeting DC vaccines.

    Measured: Study treatment scheme (i.e. from administration of first to 6th vaccine (+- 10 weeks))

  4. Feasibility of DC vaccine administration (administration of 1st vaccine)

    Proportion of efficacy evaluable patients (i.e. having received at least 1 vaccine + no major protocol violation) in the intention-to-treat population.

    Measured: At administration of first vaccine

  5. Safety of IL15/IL15Ra/WT1 DC vaccine administration: Related (Severe) Adverse Events ((S)AEs)

    Proportion of patients of the safety population that experienced (S)AEs possibly, probably or definitely related to IL15/IL15Ra/WT1 DC vaccination

    Measured: over the entire study duration (i.e. from inclusion (baseline) to end of follow-up, which lasts until 90 days after the last DC vaccine), on average 7 months

  6. Safety of IL15/IL15Ra/WT1 DC vaccine administration: total (S)AEs (number)

    Number of (S)AEs in the safety population (i.e. having received at least 1 DC vaccine)

    Measured: over the entire study duration (i.e. from inclusion (baseline) to end of follow-up, which lasts until 90 days after the last DC vaccine), on average 7 months

  7. Safety of IL15/IL15Ra/WT1 DC vaccine administration: total (S)AEs (grade)

    Grade of (S)AEs in the safety population

    Measured: over the entire study duration (i.e. from inclusion (baseline) to end of follow-up, which lasts until 90 days after the last DC vaccine), on average 7 months

Secondary outcomes (11)

  1. Indicators of clinical efficacy: Best Overall Response (BOR)

    BOR will be determined per patient as the best response designation during IL-15-transpresenting WT1-targeting DC vaccination, according to the latest version of iRECIST. The response categories are: immune complete response (iCR), immune partial response (iPR), immune stable disease (iSD) and confirmed immune progressive disease (iCPD).

    Measured: over the entire study duration (i.e. from inclusion (baseline) to end of follow-up, which lasts until 90 days after the last DC vaccine), on average 7 months

  2. Indicators of clinical efficacy: Duration of Response (DOR)

    DOR will be determined per patient as the time between the date of the first documented tumor response (iPR or iCR) and the subsequent date of the objectively documented disease progression (i.e. date of immune unconfirmed progressive disease (iUPD)) providing that iCPD is confirmed at the next assessment), or death, whichever occurs first. If iUPD occurs, but is disregarded because of later iSD, iPR or iCR, that iUPD date should not be used as the progression event date. At the time of analysis, patients without a recorded event will be censored at the time of the last objective disease assessment.

    Measured: over the entire study duration (i.e. from inclusion (baseline) to end of follow-up, which lasts until 90 days after the last DC vaccine), on average 7 months

  3. Indicators of clinical efficacy: Objective Response Rate (ORR)

    ORR is defined as the proportion of patients whose confirmed BOR is either iCR or iPR, where the denominator is the total number of patients in the efficacy evaluable population.

    Measured: over the entire study duration (i.e. from inclusion (baseline) to end of follow-up, which lasts until 90 days after the last DC vaccine), on average 7 months

  4. Indicators of clinical efficacy: Disease Control Rate (DCR)

    Proportion of patients with iCR, iPR or iSD, where the denominator is the total number of patients in the efficacy evaluable population.

    Measured: over the entire study duration (i.e. from inclusion (baseline) to end of follow-up, which lasts until 90 days after the last DC vaccine), on average 7 months

  5. Indicators of clinical efficacy: Progression-free Survival (PFS)

    PFS will be determined per patient as the time (in months) between the date of diagnosis/study entry and the first date that progression criteria are met (i.e. date of iUPD, providing that iCPD is confirmed at the next assessment). If iUPD occurs, but is disregarded because of later iSD, iPR or iCR, that iUPD date should not be used as the progression event date. At the time of analysis, patients without a recorded event will be censored at the time of the last objective disease assessment.

    If progression is not confirmed and there is no subsequent iSD, iPR or iCR then the iUPD date should still be used in the following scenarios:

    • if the patient stops study treatment because he/she was not considered to be clinically stable or no further response assessments are done (patient refusal or protocol non-compliance or patient death),
    • the next disease assessments are all iUPD and iCPD never occurs.

    Measured: over the entire study duration (i.e. from inclusion (baseline) to end of follow-up, which lasts until 90 days after the last DC vaccine), on average 7 months. PFS may be updated after study completion.

  6. Indicators of clinical efficacy: Overall Survival (OS)

    OS will be determined per patient as the time (in months) between diagnosis/study entry and death due to any cause. At the time of analysis, patients without a recorded event will be censored at the time they were last known to be alive.

    Measured: over the entire study duration (i.e. from inclusion (baseline) to end of follow-up, which lasts until 90 days after the last DC vaccine), on average 7 months. OS may be updated after study completion.

  7. Immunogenicity of vaccination with IL15/IL15Ra/WT1 DC: occurrence of WT1-specfic CD8+ T cells

    Occurrence of WT1-specific CD8+ T cells as assessed by TCR sequencing

    Measured: done on the day of administration of the first vaccine, the fourth vaccine, and on the day at the first follow-up visit following administration of V6 (i.e. +- 10 weeks after V6).

  8. Evaluation of changes in quality of life: How patients experience the study therapy

    QLQ-30

    Measured: over the entire study duration (i.e. from inclusion (baseline) to end of follow-up, which lasts until 90 days after the last DC vaccine), on average 7 months

  9. Evaluation of changes in quality of life: How patient-reported disease-related symptoms evolve over time

    QLQ-30

    Measured: over the entire study duration (i.e. from inclusion (baseline) to end of follow-up, which lasts until 90 days after the last DC vaccine), on average 7 months

  10. Evaluation of changes in quality of life: How patient-reported quality of life evolves over time

    QLQ-30

    Measured: over the entire study duration (i.e. from inclusion (baseline) to end of follow-up, which lasts until 90 days after the last DC vaccine), on average 7 months

  11. Evaluation of changes in quality of life: How patient-reported quality of life evolves over time

    EQ-5D-5L

    Measured: over the entire study duration (i.e. from inclusion (baseline) to end of follow-up, which lasts until 90 days after the last DC vaccine), on average 7 months

Timeline

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

  1. First posted27 Jul 2023
  2. Study start6 Dec 2023
  3. Primary completion22 Sep 2025
  4. Study completion22 Sep 2025

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05964361
Sponsor's protocol ID
CCRG19-001
Acronym
IL15-TransDC
Status last verified
Jun 2026
First submitted
10 Jul 2023
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Van den Bergh JM, Lion E, Van Tendeloo VF, Smits EL. IL-15 receptor alpha as the magic wand to boost the success of IL-15 antitumor therapies: The upswing of IL-15 transpresentation. Pharmacol Ther. 2017 Feb;170:73-79. doi: 10.1016/j.pharmthera.2016.10.012. Epub 2016 Oct 21.

    PubMed 27777088

  • Van den Bergh J, Willemen Y, Lion E, Van Acker H, De Reu H, Anguille S, Goossens H, Berneman Z, Van Tendeloo V, Smits E. Transpresentation of interleukin-15 by IL-15/IL-15Ralpha mRNA-engineered human dendritic cells boosts antitumoral natural killer cell activity. Oncotarget. 2015 Dec 29;6(42):44123-33. doi: 10.18632/oncotarget.6536.

    PubMed 26675759

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IL15-transpresenting WT1-targeted Dendritic Cell Vaccine in people with Esophageal Cancer and Pancreas Cancer, run by University Hospital, Antwerp at 1 site in Belgium.

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 23 inclusion and 12 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: finished, as of the sponsor's last update on 8 Jun 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 Belgium. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Feasibilty of leukapheresis (time frame: Upon completion of leukapheresis, on average 4 weeks after inclusion (baseline)). The study lists 7 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 NCT05964361, which also lists 2 linked publications.

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 8 Jun 2026.

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