Experimental vaccine targets Hard-to-Treat cancers in first human test
NCT ID NCT05964361
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested a new type of vaccine made from a patient's own immune cells (dendritic cells) that are engineered to target a protein called WT1 found in many cancers. Ten people with advanced esophageal, pancreatic, ovarian, or liver cancer received six vaccines over 12 weeks. The main goals were to see if the vaccine could be made and given safely, and to check for any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IL15/IL15Ra/WT1 dendritic cell vaccine
- What this could lead to
- If this vaccine proves safe and effective, it could offer a new treatment option for people with advanced solid tumors that have not responded to standard therapies.
- What could go wrong
- This is a very early, small trial (10 participants) focused on safety and feasibility, not on proving the vaccine works. The vaccine may not shrink tumors or improve survival.
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
-
10 people
The number who actually took part.
- Started
-
Dec 2023
- Finished
-
Sep 2025
- 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
-
18 years and older
- 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 Hide 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: * 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 * 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. Exclusion Criteria: * 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: * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Esophageal cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Antwerp University Hospital
Edegem, 2650, Belgium
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can MRI and computer models predict how well cancer drugs reach tumors?
- Can a Patient's own immune cells fight ovarian cancer?
- Ovarian Cancer's spread: scientists probe abdominal fluid for clues
- New PET tracer aims to light up hidden cancer targets
- Gut bacteria may hold clues to why some cancer treatments work better
- AI-Enhanced ultrasound aims to catch liver cancer earlier