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Gd2Il18Cart

A groundbreaking phase I clinical trial is underway to evaluate the safety, dosage, and feasibility of GD2IL18CART in patients with relapsed or refractory GD2-positive solid cancers. This innovative therapy targets advanced breast cancer, neuroblastoma, Ewing sarcoma, and osteosarcoma that have not responded to conventional treatments. The trial aims to assess the safety and effectiveness of this new approach, potentially offering hope to patients with limited treatment options.

Table of Contents

What is GD2IL18CART?

GD2IL18CART is an innovative medical treatment currently being studied for patients with certain types of cancer that have not responded well to other treatments or have come back after initial treatment[1]. It belongs to a class of treatments called Advanced Therapy Medicinal Products (ATMPs), specifically a type of cell therapy.

This therapy is personalized, meaning it uses the patient’s own immune cells. These cells, called T cells, are taken from the patient’s blood and modified in a laboratory to better fight cancer[1]. The modified cells are then given back to the patient to help their immune system combat the cancer more effectively.

How does GD2IL18CART work?

GD2IL18CART works by enhancing the patient’s own immune system to fight cancer. Here’s a simplified explanation of the process:

  1. T cells are collected from the patient’s blood.
  2. In the lab, these T cells are genetically modified using a lentiviral vector (a type of virus used to introduce new genetic material into cells).
  3. The modification allows the T cells to produce two important components:
    • A GD2CAR (Chimeric Antigen Receptor), which helps the T cells recognize and attach to cancer cells that have a specific marker called GD2 on their surface.
    • Interleukin-18 (IL-18), a protein that helps stimulate the immune system.
  4. These modified T cells (now called GD2IL18CART cells) are grown in the lab to increase their numbers.
  5. The GD2IL18CART cells are then infused back into the patient’s bloodstream[1].

Once in the body, these modified T cells can recognize and attack cancer cells that have the GD2 marker. The added IL-18 production is designed to make the treatment more effective by further boosting the immune response against the cancer.

What conditions does GD2IL18CART target?

GD2IL18CART is being studied for the treatment of several types of GD2-positive solid cancers that have either come back after initial treatment (relapsed) or have not responded well to standard treatments (refractory). The specific conditions include:

  • Neuroblastoma: A type of cancer that develops from immature nerve cells, often in young children.
  • Ewing sarcoma: A rare type of cancer that occurs in bones or in the soft tissue around the bones.
  • Osteosarcoma: The most common type of bone cancer.
  • Advanced breast cancer: Breast cancer that has spread beyond the breast and nearby lymph nodes to other parts of the body[1].

It’s important to note that for this treatment to be effective, the cancer cells must have a specific marker called GD2 on their surface. This is why part of the eligibility criteria includes testing for GD2 expression on tumor cells[1].

Clinical Trial Objectives

The current clinical trial for GD2IL18CART has several main objectives:

  1. Safety and Toxicity Assessment: The primary goal is to evaluate how safe GD2IL18CART is and what side effects it might cause[1].
  2. Dose Finding: Researchers aim to determine the recommended dose of GD2IL18CART for future use[1].
  3. Efficacy Evaluation: The trial will assess how well patients respond to the GD2IL18CART treatment[1].

Additionally, the trial has secondary objectives, including:

  • Studying how GD2IL18CART functions within the body’s immune system[1].
  • Evaluating how long the treatment’s effects last, how often the cancer comes back, and how it affects patient survival[1].

Who is eligible for GD2IL18CART treatment?

Eligibility for the GD2IL18CART clinical trial is based on specific criteria. Some key inclusion criteria are:

  • Patients must have a diagnosis of relapsed and/or refractory neuroblastoma, Ewing sarcoma, osteosarcoma, or advanced breast cancer that is considered incurable with conventional treatments[1].
  • The patient’s tumor must show GD2 expression (the target that GD2IL18CART is designed to recognize)[1].
  • Patients must be between 1 and 80 years old[1].
  • Patients must have a sufficient number of T cells in their blood[1].

There are also several exclusion criteria, including:

  • Active solid brain metastases[1].
  • Certain autoimmune diseases or central nervous system disorders[1].
  • Severe lung, heart, kidney, or liver problems[1].
  • Recent use of certain other cancer treatments[1].

It’s important to note that these are just some of the criteria. The full list is more extensive, and eligibility is determined by healthcare professionals involved in the clinical trial.

How is GD2IL18CART administered?

GD2IL18CART is administered through intravenous infusion, which means it’s delivered directly into the bloodstream through a vein[1]. The process involves several steps:

  1. Leukapheresis: This is a procedure to collect the patient’s T cells from their blood.
  2. Cell modification: The collected T cells are sent to a laboratory where they are genetically modified to become GD2IL18CART cells.
  3. Preparative chemotherapy: Before receiving the modified cells, patients typically receive chemotherapy to prepare their body for the treatment.
  4. Infusion: The modified GD2IL18CART cells are then infused back into the patient’s bloodstream.
  5. Monitoring: After the infusion, patients are closely monitored for potential side effects and to assess the treatment’s effectiveness.

Safety Considerations

As with any new medical treatment, safety is a primary concern in the GD2IL18CART clinical trial. Some important safety considerations include:

  • Side Effects: The trial is closely monitoring for any adverse events (side effects) and their severity[1].
  • Dose Finding: Part of the trial aims to find the right dose that balances effectiveness with safety[1].
  • Long-term Follow-up: Patients will be monitored for an extended period to assess long-term safety and effectiveness[1].
  • Genetic Modification: As GD2IL18CART involves genetic modification, special safety measures are in place to monitor for any unexpected effects[1].

It’s important to remember that GD2IL18CART is still in the clinical trial phase. This means that while it shows promise, its full safety profile and effectiveness are still being studied. Patients considering this treatment should discuss all potential risks and benefits with their healthcare team.

Aspect Details
Study Type Phase I safety, dose finding, and feasibility trial
Treatment GD2IL18CART (autologous T cells genetically modified to target GD2-positive cancer cells)
Target Conditions Relapsed or refractory GD2-positive solid cancers (advanced breast cancer, neuroblastoma, Ewing sarcoma, osteosarcoma)
Primary Objectives 1. Assess safety and toxicity
2. Determine recommended dose
3. Evaluate efficacy (overall response rate)
Secondary Objectives 1. Study in vivo immune function of GD2IL18CART
2. Measure duration of response, relapse rate, and survival
Key Eligibility Criteria 1. Age 1-80 years
2. GD2 expression on tumor cells
3. Evaluable disease
4. Adequate organ function
Administration Intravenous infusion

FAQ

  • What is GD2IL18CART? GD2IL18CART is an advanced therapy medicinal product (ATMP) consisting of autologous T cells that have been genetically modified to target GD2-positive cancer cells and produce interleukin-18 (IL-18). This therapy is designed to enhance the immune system's ability to fight specific types of solid cancers.
  • What types of cancers does this clinical trial target? This clinical trial focuses on patients with relapsed or refractory GD2-positive solid cancers, including advanced breast cancer, neuroblastoma, Ewing sarcoma, and osteosarcoma. These are cancers that have not responded well to conventional treatments and are considered difficult to cure.
  • What are the main objectives of this clinical trial? The primary objectives of this trial are to assess the safety and toxicity of GD2IL18CART, determine the recommended dose, and evaluate the efficacy of the treatment in terms of patient response. Secondary objectives include studying the in vivo immune function of GD2IL18CART and measuring the duration of response, relapse rate, and survival.
  • Who is eligible to participate in this clinical trial? Eligible participants include patients aged 1 to 80 years with a diagnosis of relapsed and/or refractory neuroblastoma, Ewing sarcoma, osteosarcoma, or advanced breast cancer that is considered incurable with conventional treatment. Patients must have GD2 expression on their tumor cells and meet specific criteria regarding prior treatments and current health status.
  • How is GD2IL18CART administered to patients? GD2IL18CART is administered to patients through intravenous infusion. Before receiving the therapy, patients undergo a process called leukapheresis to collect their T cells, which are then genetically modified and expanded before being infused back into the patient.

Ongoing Clinical Trials on Gd2Il18Cart

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

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

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

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • GD2IL18CART: An advanced therapy medicinal product consisting of genetically modified T cells that target GD2-positive cancer cells and produce interleukin-18 to enhance the immune response against cancer.
  • Autologous: Referring to cells or tissues that are derived from the same individual. In this context, autologous T cells are used to create the GD2IL18CART therapy.
  • GD2: A molecule found on the surface of certain cancer cells, particularly in neuroblastoma and some other solid tumors. It serves as a target for the GD2IL18CART therapy.
  • Leukapheresis: A medical procedure used to separate and collect white blood cells (including T cells) from a patient's blood. These cells are then used to create the GD2IL18CART therapy.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a standardized method to measure how well a cancer patient responds to treatment.
  • ECOG performance score: A scale used to assess a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability.
  • Lansky performance score: A scale similar to the ECOG score but used specifically for children to assess their activity levels and performance status.
  • imRECIST: Immune-modified Response Evaluation Criteria in Solid Tumors, an adaptation of RECIST criteria used to evaluate response to immunotherapy treatments.
  • ATMP: Advanced Therapy Medicinal Product, a class of innovative therapies including gene therapies, cell therapies, and tissue-engineered products.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-dosage-of-gd2il18cart-for-patients-with-relapsed-or-refractory-gd2-positive-solid-cancers/