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Long-term safety study of GD2IL18CART treatment in patients with neuroblastoma, osteosarcoma, Ewing sarcoma, or advanced breast cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on monitoring patients who have previously received treatment with GD2IL18CART, a type of cell therapy, for several types of cancer including neuroblastoma, osteosarcoma, Ewing sarcoma, and advanced breast cancer. These conditions are different types of cancers that can affect various parts of the body - neuroblastoma typically develops in nerve tissue, osteosarcoma affects bones, Ewing sarcoma can occur in bones or soft tissues, and advanced breast cancer develops in breast tissue and may spread to other parts of the body.

The main goal of this research is to understand the long-term safety of GD2IL18CART treatment. The study will follow patients who have already received this treatment to monitor how they respond over time. During the study, doctors will track any delayed side effects that might occur, including the possibility of infections, cancer returning, or new health problems developing.

The study involves regular check-ups to monitor patients' health status. For younger patients, growth and development will also be monitored. The research team will collect information about the patients' overall health and perform tests to check if the treatment cells are still present in their bodies. This long-term monitoring will help understand how the treatment affects patients over time.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial enrollment
After receiving GD2IL18CART treatment in the primary trial, you will be enrolled in this long-term follow-up study.
The follow-up period will continue until May 31, 2041.
Step 2
Regular health monitoring
Your health will be monitored for any delayed side effects or serious health issues.
The medical team will track any life-threatening infections, disease progression, or new health conditions.
For pediatric patients, height, weight, and physical development will be regularly assessed.
Step 3
Blood testing
Blood samples will be collected to check for the presence of the treatment components.
If two consecutive yearly tests show no detection, no further blood samples will be needed.
Step 4
Disease monitoring
Regular assessments will track if the disease remains stable or returns.
The medical team will monitor how long the treatment response lasts.
Your overall survival and time without disease will be documented.
Step 5
Long-term observation
The study will continue monitoring your health status for an extended period.
Any new medical conditions or secondary illnesses will be documented.
The focus will be on ensuring your safety and tracking long-term effects of the GD2IL18CART treatment.

Who can join the trial?

9 criteria

Must have previously received treatment with GD2IL18CART (a type of cell therapy) in the main clinical trial
Must be able to provide informed consent, either personally or through a caregiver, before any study-related procedures begin
Can be either male or female
Must be aged between 2-64 years old
Must have one of these conditions:
- Neuroblastoma (a type of cancer that develops from immature nerve cells)
- Osteosarcoma (a type of bone cancer)
- Ewing sarcoma (a rare type of cancer that occurs in bones or soft tissue)
- Advanced breast cancer (breast cancer that has spread beyond the breast)
- Must be willing to participate in long-term safety monitoring after treatment

Who cannot join the trial?

14 criteria

Currently pregnant women or breastfeeding mothers
People with active autoimmune diseases (conditions where the body's immune system attacks its own tissues)
Individuals with active or uncontrolled infections
Patients with severe heart problems or significant cardiovascular disease (heart and blood vessel conditions)
People with severe liver problems (liver function impairment)
Patients with severe kidney problems (kidney function impairment)
Those with active brain metastases (cancer that has spread to the brain) that are not controlled
Individuals who received other experimental treatments within the last 30 days
Patients with inadequate bone marrow function (poor blood cell production)
People with known allergies to any components of the study treatment
Patients who are currently participating in other clinical trials
Those with psychiatric conditions that could interfere with study compliance
Individuals with immunodeficiency disorders (weakened immune system conditions)
People who have had major surgery within the last 4 weeks

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Universitaetsklinikum Erlangen AöR
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Erlangen, Germany
Universitaetsklinikum Essen AöR
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Essen, Germany
Universitaetsklinikum Muenster AöR
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Munster, Germany

Trial locations

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Investigated drugs

GD2IL18CART is a type of cell therapy where a patient's own immune cells (T cells) are modified in a laboratory to better recognize and fight cancer cells. These modified cells are engineered to target a specific protein called GD2 that is found on some cancer cells, and they also contain a component called IL18 which helps boost the immune response. This is an investigational therapy being studied for its long-term effects in patients who have previously received this treatment.

Gd2Il18Cart

What is already known about the treatment

GD2IL18CART – A specialized form of cellular immunotherapy that combines CAR-T cell technology with GD2 targeting and IL-18 enhancement, administered through intravenous infusion. This experimental treatment is being studied in clinical trials for several types of cancer including neuroblastoma, osteosarcoma, Ewing sarcoma, and advanced breast cancer. The therapy works by modifying a patient's own T cells to target the GD2 protein found on cancer cells, while the IL-18 component helps enhance the immune response and improve the effectiveness of the treatment. This therapy belongs to the class of adoptive cell therapies and represents an advanced form of personalized immunotherapy that is currently under investigation for safety and efficacy in long-term follow-up studies.

Investigated diseases

Neuroblastoma
A cancer that develops from immature nerve cells, most commonly starting in the adrenal glands but can also develop in other areas. It typically occurs in young children and can present as a lump or mass in the abdomen, chest, or neck. The disease can spread to other parts of the body including bones and bone marrow.
Osteosarcoma
A type of bone cancer that typically develops in the growing bones of children and adolescents. It usually starts in areas where the bone grows quickly, such as near the ends of long bones, particularly around the knee and upper arm. The affected bone may become painful and swollen.
Ewing Sarcoma
A rare type of cancer that occurs in bones or in the soft tissue around bones. It most commonly affects children and young adults, typically appearing in the pelvis, leg bones, or chest wall. The affected area may become painful and swollen, sometimes accompanied by fever.
Advanced Breast Cancer
A stage of breast cancer where cancer cells have spread beyond the original tumor site to other parts of the body. It develops when abnormal cells in breast tissue multiply and grow uncontrollably. The disease can affect nearby lymph nodes and spread to other organs through the bloodstream or lymphatic system.