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Study of Afamitresgene Autoleucel for Patients with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

Verified siteInvestigationalNo placebo
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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 studying two types of cancer: Advanced Synovial Sarcoma and Myxoid/Round Cell Liposarcoma. These are rare forms of cancer that affect soft tissues in the body. The treatment being tested in this study is called Afamitresgene autoleucel, which is a type of cell therapy. This treatment involves using genetically modified T cells, which are a part of the immune system, to target and fight the cancer cells.

The purpose of the study is to evaluate how effective this new treatment is for patients with these specific types of cancer. Participants in the study will receive the treatment through an infusion, which means the medicine is given directly into the bloodstream through a vein. The study will follow participants over a period of time to monitor their response to the treatment and any side effects they may experience.

Throughout the study, researchers will collect information on how well the treatment works in shrinking the tumors and improving the patients' health. They will also keep track of any adverse effects to ensure the safety of the participants. The study aims to provide valuable insights into the potential benefits of Afamitresgene autoleucel for treating these challenging cancers.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must provide written informed consent, agreeing to participate in the trial and follow all required procedures.

    Eligibility is confirmed through various criteria, including age, medical history, and specific genetic markers.

  2. Step 2

    Pre-treatment assessments

    Before treatment begins, the patient undergoes assessments to ensure adequate organ function and overall health status.

    Tests include blood work, imaging, and other evaluations to establish a baseline for monitoring throughout the trial.

  3. Step 3

    Leukapheresis

    The patient undergoes a procedure called leukapheresis, which involves collecting white blood cells from the bloodstream.

    This step is necessary for the preparation of the genetically modified T cells used in the treatment.

  4. Step 4

    Cell modification and preparation

    The collected cells are sent to a laboratory where they are genetically modified to target cancer cells.

    This process involves the creation of ADP-A2M4 SPEAR™ T cells, which are designed to recognize and attack specific cancer cells.

  5. Step 5

    Lymphodepletion chemotherapy

    Before receiving the modified T cells, the patient undergoes a short course of chemotherapy to reduce the number of existing immune cells.

    This step, known as lymphodepletion, helps the modified T cells to function more effectively.

  6. Step 6

    Infusion of modified T cells

    The patient receives an infusion of the genetically modified T cells, known as afamitresgene autoleucel, through an intravenous route.

    This infusion is a critical part of the treatment, aiming to target and destroy cancer cells.

  7. Step 7

    Post-infusion monitoring

    After the infusion, the patient is closely monitored for any side effects or adverse reactions.

    Regular follow-up visits are scheduled to assess the treatment's effectiveness and the patient's overall health.

  8. Step 8

    Long-term follow-up

    The patient continues to be monitored over an extended period to evaluate the long-term effects of the treatment.

    This includes regular health assessments and possibly additional treatments if necessary.

Who can join the trial?

13 criteria

  • The patient or their legal representative must agree to participate by signing a written consent form.
  • The heart's pumping ability, known as the left ventricular ejection fraction (LVEF), must be 50% or higher.
  • The patient must be fit for a procedure called leukapheresis, which involves collecting blood cells, and have suitable veins for this procedure.
  • Women who can have children must have a negative pregnancy test and agree to use effective birth control starting from the first dose of chemotherapy and continuing for at least 12 months, or 4 months after the modified cells are no longer found in the blood, whichever is longer. Men must be surgically sterile or agree to use two forms of birth control or abstain from sex with women who can have children, starting from the first dose of chemotherapy and continuing for 4 months afterward.
  • The patient must have proper organ function as shown by specific lab tests.
  • The patient or their legal representative must agree to follow all study procedures and assessments for the entire duration of the study, including long-term follow-up.
  • The patient must be between 16 and 75 years old at the time of signing the consent form.
  • The patient must have a confirmed diagnosis of advanced synovial sarcoma or myxoid liposarcoma, which means the cancer has spread or cannot be removed by surgery without causing significant harm.
  • The patient must have previously received a treatment containing either anthracycline or ifosfamide. If they cannot tolerate these, they must have received at least one other type of treatment.
  • The patient must have a measurable disease according to specific criteria before a treatment called lymphodepletion.
  • The patient must test positive for certain genetic markers called HLA-A*02 alleles through a designated laboratory test.
  • The patient's tumor must show a certain level of a protein called MAGE-A4 in at least 30% of the cells, confirmed by a laboratory review.
  • The patient must have an ECOG Performance Status of 0 or 1, which indicates they are fully active or have some symptoms but can carry out light work.

Who cannot join the trial?

7 criteria

  • Patients who do not have **Myxoid/Round Cell Liposarcoma** or **Advanced Synovial Sarcoma** cannot participate.
  • Patients who are not **HLA-A*02 positive** cannot participate. This means their body does not have a specific type of protein on their cells.
  • Patients whose cancer does not express **MAGE-A4** cannot participate. This means their cancer cells do not have a specific marker that the study is looking for.
  • Patients who are not within the specified age range cannot participate. The study includes certain age groups only.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of participants.
  • Both male and female patients are eligible, so gender is not an exclusion criterion.
  • Patients who are considered part of a vulnerable population may not be eligible. This refers to groups who might need special protection in research studies.
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Investigated drugs

ADP-A2M4 SPEAR™ T cells are a type of therapy used in this clinical trial. These are specially modified T cells that are taken from the patient's own body. They are genetically altered to better recognize and attack cancer cells. In this study, they are used to treat patients with advanced synovial sarcoma or myxoid/round cell liposarcoma, which are specific types of cancer. The goal is to see how effective these modified T cells are in targeting and fighting the cancer in patients who have a specific genetic marker called HLA-A*02 and whose cancer cells express a protein known as MAGE-A4.

What is already known about the treatment

ADP-A2M4 – This medication is administered through an infusion of genetically modified T cells, specifically designed for patients with certain types of advanced sarcomas. It is currently being studied in clinical trials and is not yet widely available in standard medical practice. The main therapeutic indications include advanced synovial sarcoma and myxoid/round cell liposarcoma. The mechanism of action involves the modification of T cells to target and attack cancer cells expressing the MAGE-A4 protein, which is present in these tumors. It falls under the pharmacological classification of gene therapy and immunotherapy.

Investigated diseases

  • Myxoid/Round Cell Liposarcoma

    This is a type of cancer that originates in fat cells and is characterized by a mix of myxoid (gel-like) and round cell components. It typically occurs in the deep soft tissues of the limbs, particularly the thighs. The disease progresses as the tumor grows and may spread to other parts of the body, such as the lungs. The myxoid component is usually more common, but as the round cell component increases, the tumor becomes more aggressive. Patients may experience swelling or a noticeable mass in the affected area. The progression can vary, with some tumors growing slowly while others may advance more rapidly.

  • Advanced Synovial Sarcoma

    This is a rare type of cancer that arises in the tissues around joints, such as tendons and ligaments. It is called "synovial" because it resembles the synovial tissue found in joints, although it does not originate from it. The disease often affects young adults and can occur in any part of the body, but it is most commonly found in the arms or legs. As it progresses, the tumor may grow larger and invade nearby tissues, potentially spreading to other areas like the lungs. Symptoms can include a painful or painless mass, swelling, and reduced range of motion in the affected joint. The progression of synovial sarcoma can vary, with some cases remaining localized while others may metastasize.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512847-21-00Protocol codeADP-0044-002Estimated enrolment179 patientsSponsorUSWM Ct LLC

sourced from the EU Clinical Trials Register and site verification

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