Study on WT1/IL15/IL15Ra mRNA DC Vaccine for Patients with Advanced or Refractory Solid Tumors of the Pancreas, Esophagus, Liver, or Ovaries

2 1 1

What is this study about?

This clinical trial is focused on studying certain types of cancer, specifically those affecting the pancreas, esophagus, liver, and ovaries. These cancers are advanced, have come back, or are getting worse after initial treatments. The study is testing a new treatment called WT1/IL15/IL15Ra mRNA DC, which is a type of vaccine made from a patient’s own cells. This vaccine is designed to help the immune system recognize and fight cancer cells more effectively.

The purpose of the study is to see if this new vaccine can be safely made and given to patients with these types of cancer. The vaccine is given as an injection just under the skin. Patients will receive the vaccine and be monitored to see how their bodies respond to the treatment. The study will also look at how the vaccine affects the patients’ quality of life and how their cancer responds to the treatment over time.

Throughout the study, researchers will keep track of any side effects and how well the vaccine is working. The goal is to find out if this new approach can be a safe and effective option for people with these challenging types of cancer. The study is expected to continue until 2026, with the hope of providing new insights into cancer treatment.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including a confirmed diagnosis of a solid tumor in the pancreas, esophagus, liver, or ovaries that is advanced or recurrent.

The patient must have at least one measurable lesion and a reasonable life expectancy of at least three months.

2 leukapheresis procedure

A procedure called leukapheresis is performed to collect white blood cells from the patient. This is necessary for the production of the personalized vaccine.

3 vaccine production

The collected cells are used to produce the WT1/IL15/IL15Ra mRNA DC vaccine. This process involves ensuring the vaccine meets all quality control standards.

4 vaccine administration

The vaccine is administered through an intradermal injection. The schedule and dosage are determined by the study protocol.

The primary goal is to evaluate the safety and feasibility of the vaccine administration.

5 monitoring and follow-up

The patient is monitored for any adverse effects (AEs) or serious adverse effects (SAEs) during and after the vaccine administration.

The study also assesses the clinical efficacy, including the overall response and progression-free survival.

6 quality of life assessment

Throughout the trial, the patient’s quality of life is evaluated, focusing on how the therapy is experienced and how disease-related symptoms evolve.

Who Can Join the Study?

  • You must have a confirmed solid tumor in the pancreas, esophagus, liver, or ovaries. This means that tests have shown the presence of cancer cells in these areas.
  • Your cancer must be advanced, recurrent, or getting worse after at least one type of anti-cancer treatment. Alternatively, there should be no other standard treatment options available for you, either because you cannot tolerate them or you have chosen not to undergo them.
  • You need to have at least one measurable or evaluable lesion. This means there should be a tumor or area of cancer that can be measured or assessed using specific medical criteria.
  • You should have a reasonable life expectancy of at least 3 months, as determined by the doctor conducting the study.
  • You must be 18 years or older at the time you agree to participate in the study.
  • Your performance status should be between 0 and 2 according to the World Health Organization (WHO) scale. This scale measures how well you can carry out daily activities.
  • You need to have adequate hematologic and end-organ function. This means your blood and major organs, like the liver and kidneys, should be working well enough to participate in the study.

Who Cannot Join the Study?

  • Patients who have not been diagnosed with a solid tumor in the pancreas, esophagus, liver, or ovaries.
  • Patients whose tumors are not advanced, recurrent, or progressing after at least one anti-cancer treatment.
  • Patients who have alternative standard therapy options available and are not intolerant or refusing standard treatment.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not considered part of the vulnerable population selected for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Uhiikwkqdl Of Akwwbhw Edegem Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
06.12.2023

Trial locations

IL-15-transpresenting WT1-targeted DC vaccine is a new type of treatment being tested in this clinical trial. It is designed to help the body’s immune system fight cancer. This vaccine uses a special protein called interleukin-15 (IL-15) to help the immune system recognize and attack cancer cells. The vaccine is made from the patient’s own cells, which are modified to target a specific protein found in some cancer cells, known as the Wilms’ tumor protein 1 (WT1). The goal of this treatment is to see if it is safe and if it can help treat patients with advanced or hard-to-treat solid tumors.

Investigated diseases:

Pancreatic Cancer – This is a type of cancer that begins in the tissues of the pancreas, an organ in the abdomen that lies behind the lower part of the stomach. It often progresses silently, with symptoms appearing only in advanced stages. As it advances, it may cause abdominal pain, weight loss, and jaundice. The cancer can spread to nearby organs and lymph nodes, making it more challenging to manage. It is often diagnosed at a late stage due to its subtle early symptoms.

Esophageal Cancer – This cancer occurs in the esophagus, the long tube that carries food from the throat to the stomach. It typically begins in the cells lining the inside of the esophagus and can grow to invade deeper layers and nearby structures. As it progresses, it may cause difficulty swallowing, weight loss, and chest pain. The disease can spread to lymph nodes and other organs, complicating treatment. Early symptoms are often mild, leading to late diagnosis.

Liver Cancer – This type of cancer starts in the cells of the liver, an organ located in the upper right portion of the abdomen. It can develop from different types of liver cells, but the most common form is hepatocellular carcinoma. As it progresses, it may cause symptoms like weight loss, upper abdominal pain, and jaundice. The cancer can spread to other parts of the body, including the lungs and bones. It is often associated with chronic liver diseases such as cirrhosis.

Ovarian Cancer – This cancer begins in the ovaries, the female reproductive glands that produce eggs. It often goes undetected until it has spread within the pelvis and abdomen. As it progresses, it may cause abdominal bloating, pelvic pain, and changes in bowel habits. The disease can spread to the lining of the abdomen and other organs, making it more difficult to treat. Early-stage ovarian cancer rarely causes any symptoms, leading to late-stage diagnosis.

Trial ID:
2024-515296-35-00
Protocol code:
IL15 TransDC
NCT ID:
NCT05964361
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

Other Trials to Consider

  • Study on the Safety and Effects of VERT-002 for Patients with Advanced Solid Tumors, Including Lung Cancer with MET Alterations

    Recruiting

    2 1 1
    Investigated drugs:
    Belgium France Germany Italy The Netherlands Spain
  • Telisotuzumab Adizutecan for Locally Advanced or Metastatic Solid Tumors with MET Amplification in Patients 12 Years and Older

    Recruiting

    2 1 1
    Investigated diseases:
    Denmark France Spain