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Study of Letetresgene Autoleucel for Patients with Synovial Sarcoma and 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: 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 GSK3377794, which is a type of cell therapy. This treatment involves using the patient's own immune cells, specifically T cells, which are modified in a laboratory to better recognize and attack cancer cells. The modified T cells are then infused back into the patient's body to help fight the cancer.

The purpose of the study is to evaluate how effective and safe this treatment is for patients with these specific types of cancer. Participants in the study will receive the GSK3377794 treatment, and some may also receive other anti-cancer agents. The study will monitor how the cancer responds to the treatment and any side effects that may occur. The treatment is given through an infusion, which means it is delivered directly into the bloodstream through a vein.

Throughout the study, participants will have regular check-ups to assess their health and the progress of the treatment. The study aims to provide valuable information on whether this new approach can help improve outcomes for patients with synovial sarcoma and myxoid/round cell liposarcoma. The study is expected to continue until 2025, allowing researchers to gather comprehensive data on the treatment's effectiveness and safety.

The research process

The trial runs in 6 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, eligibility is confirmed through specific criteria, including age, weight, and health status.

    A diagnosis of synovial sarcoma or myxoid/round cell liposarcoma is required, with evidence of specific genetic markers.

  2. Step 2

    Leukapheresis procedure

    Leukapheresis is a procedure to collect white blood cells. This is necessary for the preparation of the treatment.

    Eligibility is reassessed before this procedure, ensuring adequate health and organ function.

  3. Step 3

    Treatment preparation

    The collected cells are genetically modified to target cancer cells. This process involves engineering the cells to express NY-ESO-1-specific T cells.

    This step is crucial for the personalized treatment approach.

  4. Step 4

    Treatment administration

    The modified T cells, known as GSK3377794, are administered through an intravenous infusion.

    The infusion is a one-time procedure, and the dosage is tailored to the individual's needs.

  5. Step 5

    Monitoring and follow-up

    After the infusion, regular monitoring is conducted to assess the treatment's effectiveness and safety.

    This includes evaluating the overall response rate and monitoring for any adverse effects.

  6. Step 6

    End of study participation

    The study is estimated to conclude by March 31, 2025.

    Participants will be informed of the study's outcomes and any further steps if necessary.

Who can join the trial?

14 criteria

  • If you are under 18 years old, your legal guardian must give permission for you to join the study. You will also be included in discussions to agree to participate.
  • You must be at least 10 years old when you agree to join the study. If you are scheduled to receive a specific drug and weigh less than 40 kg, the study doctor must consult with a medical expert before including you.
  • You must have a confirmed diagnosis of **synovial sarcoma** or **myxoid/round cell liposarcoma**, which are specific types of cancer.
  • Your cancer must be advanced, meaning it has spread to other parts of the body or cannot be removed by surgery.
  • Both males and females can participate. You must follow birth control guidelines during certain parts of the study.
  • A sample of your tumor tissue must be available for testing, unless a recent test has already been done under a related study.
  • You must have a life expectancy of at least 24 weeks.
  • Your cancer must show specific genetic changes, known as **translocations**, which are changes in the arrangement of chromosomes. For synovial sarcoma, this involves certain genes on chromosomes 18 and X. For myxoid/round cell liposarcoma, this involves certain genes on chromosomes 12, 16, and 22.
  • You must be currently receiving or have completed at least one standard treatment for advanced disease, which includes drugs like doxorubicin. If you cannot tolerate these drugs, other options may be considered.
  • You must test positive for specific genetic markers called **HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06** before a procedure called leukapheresis, which collects certain blood cells.
  • Your tumor must show a positive result for a protein called **NY-ESO-1**, with at least 30% of cells showing this protein.
  • Your heart must be functioning well, with a **left ventricular ejection fraction** of at least 45%, and no significant fluid around the heart.
  • You must have a certain level of physical ability, measured by different scales depending on your age.
  • Your organs and blood cell counts must be functioning adequately before the leukapheresis procedure.

Who cannot join the trial?

3 criteria

  • Patients who do not have the specific types of cancer being studied, which are Synovial sarcoma and Myxoid/Round Cell Liposarcoma (MRCLS).
  • Patients whose tumors do not have the specific markers called NY ESO 1 and/or LAGE-1a.
  • Patients who do not have the specific genetic markers called HLA-A*02:01, HLA A*02:05, and/or HLA A*02:06.
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Investigated drugs

  • NY-ESO-1-Specific (c259) T Cells

    are a type of genetically engineered immune cell therapy. These T cells are designed to recognize and attack cancer cells that express specific proteins called NY-ESO-1 and LAGE-1a. The therapy involves collecting T cells from the patient, modifying them in a laboratory to target these proteins, and then infusing them back into the patient to help fight the cancer.

  • Anti-Cancer Agents

    are medications used in combination with the NY-ESO-1-specific (c259) T cells to enhance their effectiveness. These agents work in various ways to help stop the growth of cancer cells, kill them, or prevent them from spreading. The specific anti-cancer agents used in the trial are not named, but they are chosen to complement the action of the T cell therapy.

What is already known about the treatment

NY-ESO-1-Specific (c259) T Cells – This medication is administered through infusion, where genetically engineered T cells are introduced into the patient's bloodstream. It is currently being studied in clinical trials for its potential to treat certain types of cancer, specifically synovial sarcoma and myxoid/round cell liposarcoma. The main therapeutic indication is for solid tumors that express NY-ESO-1 and/or LAGE-1a proteins. At the molecular level, these T cells are designed to recognize and attack cancer cells expressing these proteins. This medication falls under the pharmacological classification of immunotherapy, as it utilizes the body's immune system to target and destroy cancer cells.

Investigated diseases

  • Synovial Sarcoma

    This is a rare type of cancer that usually occurs near the joints of the arm, neck, or leg. It is characterized by the presence of spindle cells and can affect both soft tissues and bones. The disease often begins as a slow-growing mass, which may not cause symptoms until it becomes larger. As it progresses, it can invade nearby tissues and may spread to other parts of the body, such as the lungs. Synovial sarcoma is more common in young adults and adolescents.

  • Myxoid/Round Cell Liposarcoma (MRCLS)

    This is a subtype of liposarcoma, a cancer that arises in fat cells in deep soft tissue. It is characterized by a mix of myxoid (mucous-like) and round cell components. The disease typically presents as a painless, enlarging mass in the thigh or retroperitoneum. As it progresses, it can infiltrate surrounding tissues and has the potential to metastasize, particularly to the lungs. MRCLS is more frequently diagnosed in adults and can vary in its rate of growth and spread.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513032-14-00Protocol code208467Estimated enrolment87 patientsSponsorUSWM Ct LLC

sourced from the EU Clinical Trials Register and site verification

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