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Long-Term Follow-Up Study for Patients with Myxoid/Round Cell Liposarcoma, Multiple Myeloma, Non-Small Cell Lung Cancer, or Synovial Sarcoma Treated with Letetresgene Autoleucel

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 the long-term follow-up of participants who have been treated with a type of therapy known as adoptive cell therapy. The diseases being studied in this trial include myxoid/round cell liposarcoma, multiple myeloma, non-small cell lung cancer, and synovial sarcoma. The treatment being used is called GSK3377794, which is an advanced therapy involving genetically modified cells. These cells are designed to help the body's immune system target and fight cancer cells more effectively.

The purpose of the study is to monitor participants for any delayed side effects that might occur after receiving this cell therapy. Participants in this study have already received at least one infusion of the therapy and have completed a previous study or treatment program. The study will involve regular check-ups to observe any new health issues, such as new cancers, neurological disorders, autoimmune disorders, blood disorders, or infections that could be related to the cell therapy.

Throughout the study, participants will have their blood tested to check for specific DNA markers and to monitor the presence of the genetically modified cells. The study will also track any serious health events, including hospitalizations or unexpected illnesses, to ensure the safety and effectiveness of the treatment over time. The study is expected to continue until 2032, providing valuable information on the long-term effects of this innovative therapy.

The research process

The trial runs in 5 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    Upon joining the study, participants must have completed a previous study involving adoptive cell therapy or have withdrawn from it as per the protocol.

    Participants must provide informed consent, which includes understanding the study requirements and restrictions.

  2. Step 2

    Treatment administration

    Participants receive an infusion of GSK3377794, which contains genetically modified cells known as letetresgene autoleucel.

    The infusion is administered intravenously, meaning it is delivered directly into the bloodstream.

  3. Step 3

    Monitoring for side effects

    Participants are monitored for any delayed side effects that may occur due to the genetically modified cells.

    These side effects may include new cancers, neurological disorders, autoimmune disorders, blood disorders, infections, or unexpected illnesses related to the therapy.

  4. Step 4

    Blood sample analysis

    Blood samples are collected to analyze the presence of specific DNA sequences, such as Vesicular Stomatitis Virus G protein (VSV-G) and Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE).

    The integration patterns of the vector sequences in the blood are also studied to understand the therapy's effects.

  5. Step 5

    Long-term follow-up

    Participants are followed up over a long period to monitor their health and any long-term effects of the therapy.

    The study is estimated to continue until April 2032, ensuring comprehensive monitoring and data collection.

Who can join the trial?

14 criteria

  • Participants must have received at least one infusion of an Adaptimmune adoptive cell therapy agent.
  • Participants must have completed an Adaptimmune sponsored or supported interventional study or have withdrawn from it, as defined by the interventional protocol.
  • Participants who have completed treatment as part of managed access to an adoptive cell therapy are eligible.
  • Participants who complete an interventional study must complete the assessments outlined in the interventional protocol before starting this study.
  • Both male and female participants are eligible.
  • Male participants must agree to use contraception starting at the first dose of chemotherapy and for at least 12 months after receiving the cell therapy infusion, or until the gene-modified cells are no longer detectable for two consecutive assessments, whichever is longer.
  • If male participants received pembrolizumab during the interventional study, they must use effective contraception for at least 4 months after the last dose of pembrolizumab if this period is longer than the required duration for chemotherapy and gene-modified cells.
  • Male participants must refrain from donating sperm and either remain abstinent or use a male condom during sexual activity.
  • Female participants are eligible if they are not a woman of childbearing potential (WOCBP) or if they agree to use a highly effective contraceptive method for at least 12 months after receiving the T-cell infusion, or until the gene-modified cells are no longer detectable for two consecutive assessments, whichever is longer.
  • If WOCBP participants received pembrolizumab during the interventional study, they must use effective contraception for at least 4 months after the last dose of pembrolizumab if this period is longer than the required duration for chemotherapy and gene-modified cells.
  • WOCBP should not donate eggs for reproduction during this period.
  • The investigator will evaluate the effectiveness of the contraceptive method and review medical history, menstrual history, and recent sexual activity to reduce the risk of including a woman with an early undetected pregnancy in the study.
  • Participants must be capable of giving signed informed consent, which means they understand and agree to the study's requirements and restrictions.
  • For participants under 18 years of age (or the legal minimum age in the relevant country), their legal guardian must give informed consent. Pediatric participants will be included in age-appropriate discussions to obtain assent as per local requirements.

Who cannot join the trial?

4 criteria

  • Patients with **Myxoid/round cell liposarcoma (MRCLS)** cannot participate.
  • Patients with **Multiple Myeloma** and other similar conditions cannot participate.
  • Patients with **Non-small cell lung cancer (NSCLC)** cannot participate.
  • Patients with **Synovial sarcoma** cannot participate.
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Investigated drugs

Adoptive Cell Therapies are treatments that involve using a patient's own immune cells, which are collected and then modified in a laboratory to better fight cancer or other diseases. These modified cells are then infused back into the patient to help their immune system target and destroy diseased cells more effectively. The trial aims to monitor participants for any delayed adverse effects that might occur after receiving these genetically modified cells.

What is already known about the treatment

Adoptive Cell Therapy – This treatment is administered through an infusion, where genetically modified cells are introduced into the patient's bloodstream. Currently, it is being studied in clinical trials for its effectiveness in treating conditions like myxoid/round cell liposarcoma, multiple myeloma, non-small cell lung cancer, and synovial sarcoma. The therapy works by using the patient's own immune cells, which are modified to better recognize and attack cancer cells. It falls under the pharmacological classification of immunotherapy, specifically focusing on enhancing the body's natural defenses to fight cancer.

Investigated diseases

  • Myxoid/Round Cell Liposarcoma (MRCLS)

    This is a rare type of cancer that arises in fat tissue, often occurring in the limbs or abdomen. It is characterized by a mix of myxoid (gelatinous) and round cell components. The disease typically progresses slowly, but the round cell component can lead to more aggressive behavior. Patients may notice a painless lump or swelling as the tumor grows. Over time, the tumor can invade nearby tissues and may spread to other parts of the body.

  • Multiple Myeloma

    This is a cancer of plasma cells, which are a type of white blood cell found in the bone marrow. It leads to the accumulation of abnormal plasma cells, which can crowd out healthy blood cells. As the disease progresses, it can cause bone pain, fractures, and anemia. Patients may also experience kidney problems and increased susceptibility to infections. The disease often progresses in a series of relapses and remissions.

  • Non-Small Cell Lung Cancer (NSCLC)

    This is the most common type of lung cancer, accounting for about 85% of cases. It includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. The disease typically progresses by forming a tumor in the lungs, which can grow and spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and difficulty breathing. As the cancer advances, it can invade nearby tissues and organs.

  • 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 progresses slowly, but it can become aggressive and spread to other parts of the body. Patients may notice a swelling or mass that can be painful or restrict movement. Over time, the tumor can invade surrounding tissues and may metastasize.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-513033-21-00Protocol code208750/04Estimated enrolment73 patientsSponsorUSWM Ct LLC

sourced from the EU Clinical Trials Register and site verification

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