Recruiting

Study on the Safety and Dosage of GD2IL18CART for Patients with Relapsed or Refractory GD2 Positive Solid Cancers

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What is this trial about?

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

This clinical trial is focused on testing a new treatment called GD2IL18CART for patients with certain types of cancer that have returned or are not responding to standard treatments. The cancers being studied include neuroblastoma, Ewing sarcoma, osteosarcoma, and advanced breast cancer. The treatment involves using a special type of cell therapy, where a patient's own immune cells, known as T cells, are modified outside the body to better recognize and attack cancer cells. This modification is done using a gene called GD2CAR-IL18, which helps the T cells target and destroy cancer cells more effectively.

The purpose of the study is to determine the safety and appropriate dosage of GD2IL18CART and to see how well it works in treating these cancers. Participants will receive the treatment through an intravenous infusion, which means it will be delivered directly into the bloodstream. The study will monitor participants for any side effects and measure how the cancer responds to the treatment over time. Some participants may receive a placebo, which is a substance with no active treatment, to compare the effects of the new therapy.

Throughout the study, researchers will carefully observe the participants' health and the behavior of the cancer. The study aims to find the best dose of GD2IL18CART that is both safe and effective. Participants will be followed for a period to assess the treatment's impact on their cancer and overall health. This trial is an important step in developing new therapies for cancers that are difficult to treat with existing methods.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the trial, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of relapsed or refractory neuroblastoma, Ewing sarcoma, osteosarcoma, or advanced breast cancer.
The assessment also involves checking the expression of GD2 on tumor cells through a biopsy, and evaluating the disease using imaging techniques or bone marrow biopsy for neuroblastoma.
Step 2
Pre-treatment evaluation
A comprehensive evaluation is performed to assess overall health and readiness for treatment. This includes blood tests to measure T cell count and performance scores to ensure physical capability.
Women of childbearing potential undergo a pregnancy test to confirm eligibility.
Step 3
Treatment initiation
The treatment phase begins with the administration of GD2IL18CART through an intravenous infusion. The dosage is determined based on safety and efficacy assessments.
The primary objective is to evaluate the safety and potential side effects of the treatment.
Step 4
Monitoring and dose adjustment
Regular monitoring is conducted to observe the body's response to the treatment. This includes tracking any adverse effects and adjusting the dose if necessary.
The goal is to find the recommended dose that balances effectiveness with minimal side effects.
Step 5
Response evaluation
At week 12, the response to the treatment is evaluated. This involves assessing the rate of complete or partial remissions using imaging techniques.
The overall response rate is determined to understand the effectiveness of the treatment.
Step 6
Long-term follow-up
Patients are followed up for a year to monitor the persistence of the treatment's effects and overall survival.
This phase includes evaluating the duration of response, relapse rate, and time to relapse.

Who can join the trial?

18 criteria

Patients must have a diagnosis of relapsed or refractory **neuroblastoma**, **Ewing sarcoma**, **osteosarcoma**, or **advanced breast cancer** that cannot be cured with standard treatments.
For patients with advanced breast cancer:
- Those with **hormone receptor positive** disease must have tried all hormone therapy options, including a combination with a CDK4/6 inhibitor, and chemotherapy should not be a suitable option.
- Those with **HER2 positive** disease should have received specific treatments like Trastuzumab-Emtansin (T-DM1) or T-DXd after initial therapy.
- Those with **triple negative** disease must have had at least two prior chemotherapy treatments, including Sacituzumab-Govitecan, and if they have certain scores, they should have received an immune checkpoint inhibitor.
- For **neuroblastoma**:
  - Patients with local recurrence must have had surgery or radiotherapy followed by chemotherapy.
  - Patients with widespread recurrence after being classified as intermediate risk must have received high-risk therapy.
  - Patients with recurrence after being classified as high risk must have received chemotherapy alone or with immunotherapy.
  - For **Ewing sarcoma**:
    
    Patients must have received initial therapy and at least one prior chemotherapy treatment for relapse.
    Patients with a lung relapse must have received lung irradiation during initial or relapse therapy.
    For **osteosarcoma**:
    
    Patients must have received initial therapy and at least one prior chemotherapy treatment for relapse.
    Patients with a specific type of relapse (lung or local) must have disease that cannot be surgically removed.
    **GD2 expression** must be present on tumor cells, which means a certain percentage of tumor cells must show GD2 using a special test.
    Patients must have a disease that can be measured using specific medical scans or tests.
    Patients must be between the ages of 1 and 79 years old.
    Patients must have a certain number of **CD3+ T cells**, which are a type of immune cell, in their blood.
    Patients over 16 years old must have an **ECOG performance score** of 0-2, which measures their ability to perform daily activities. Those 16 or younger must have a **Lansky performance score** of 60 or higher.
    Women who can have children must have a negative pregnancy test at the start and before chemotherapy.
    Patients and/or their parents must sign and date a consent form before any trial-specific procedures are done.

Who cannot join the trial?

10 criteria

Patients with a history of severe allergic reactions to similar treatments.
Individuals who are currently pregnant or breastfeeding.
Patients with uncontrolled infections that are not responding to treatment.
Individuals with other serious health conditions that could interfere with the study.
Patients who have received another experimental treatment within the last 30 days.
Individuals with a history of certain heart problems, such as heart failure or irregular heartbeat.
Patients with active autoimmune diseases, which are conditions where the immune system attacks the body.
Individuals who are unable to follow the study procedures or attend required visits.
Patients with a history of substance abuse that could affect their ability to participate.
Individuals who have had a 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
Verified
Essen, Germany
Universitaetsklinikum Muenster AöR
Verified
Munster, Germany

Trial locations

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Investigated drugs

GD2IL18CART is a type of therapy being tested in this clinical trial. It is a treatment designed for patients with certain types of solid cancers that have returned or are not responding to other treatments. This therapy involves using the patient's own immune cells, which are modified to better recognize and attack cancer cells that have a specific marker called GD2. The goal of this trial is to find a safe and effective dose of GD2IL18CART and to see how well it works in treating these cancers.

What is already known about the treatment

GD2IL18CART – This medication is administered through infusion, specifically targeting patients with certain types of solid tumors. It is currently in the early stages of clinical trials, focusing on its safety and appropriate dosing. The main therapeutic indications include Ewing sarcoma, advanced breast cancer, osteosarcoma, and neuroblastoma. At the molecular level, GD2IL18CART works by modifying the patient's own immune cells to better recognize and attack cancer cells expressing the GD2 antigen. It falls under the pharmacological classification of CAR T-cell therapies, which are a type of immunotherapy designed to enhance the body's natural defenses against cancer.

Investigated diseases

Ewing sarcoma
Ewing sarcoma is a rare type of cancer that occurs in bones or in the soft tissue around the bones. It primarily affects children and young adults. The disease often begins in the long bones of the arms and legs, pelvis, or chest. It can cause pain, swelling, and sometimes a palpable lump. As it progresses, it may spread to other parts of the body, including the lungs and other bones.
Advanced breast cancer
Advanced breast cancer refers to breast cancer that has spread beyond the breast to other parts of the body. This stage is also known as metastatic breast cancer. It can affect organs such as the liver, lungs, brain, or bones. Symptoms may include persistent pain, fatigue, and changes in appetite. The disease can progress at varying rates, depending on numerous factors, including the cancer's biology and the patient's overall health.
Osteosarcoma
Osteosarcoma is a type of bone cancer that typically starts in the long bones, such as those in the arms and legs. It is most common in teenagers and young adults. The disease often causes pain and swelling in the affected area. As it advances, it can lead to fractures and may spread to other parts of the body, particularly the lungs. The progression can vary, with some cases remaining localized while others spread more rapidly.
Neuroblastoma
Neuroblastoma is a cancer that develops from immature nerve cells found in several areas of the body. It most commonly affects children, particularly those under the age of five. The disease often begins in the adrenal glands but can also develop in the neck, chest, abdomen, or spine. Symptoms can include abdominal pain, a lump in the abdomen, and changes in bowel habits. As it progresses, neuroblastoma can spread to other parts of the body, including the bones and bone marrow.