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Active not recruitingPHASE2INTERVENTIONAL

Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Treated Advanced (Metastatic or Unresectable) Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

This study is testing a new type of treatment called Lete-Cel. This treatment uses specially engineered cells from your own body to fight certain advanced cancers, specifically synovial sarcoma and myxoid/round cell liposarcoma. These are rare types of cancer that have spread or cannot be removed by surgery. The main goal is to find out if Lete-Cel is safe and how well it works in people who have already had standard treatments that didn't stop the cancer. The study is for people aged 10 and over and involves checking if their cancer cells have specific markers. It's a second-stage study, meaning it has already passed initial safety tests.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
USWM CT, LLC
Enrolment target
87
Start
31 Dec 2019
Estimated completion
31 Jul 2026

What is this study about?

This study is looking at a new treatment called Lete-Cel for two types of rare cancer: synovial sarcoma and myxoid/round cell liposarcoma. These cancers are considered 'advanced' because they have either spread to other parts of the body (metastatic) or cannot be removed through surgery. When we say 'unresectable', it means surgery would be too risky or wouldn't get rid of all the cancer without causing severe problems.

Lete-Cel is a special kind of cell therapy. It involves taking some of your own immune cells, called T-cells, and changing them in a lab so they are better at finding and fighting cancer. These specially trained cells are then given back to you. The idea is that these altered T-cells will target specific markers found on your cancer cells, helping your body to fight the disease. This study is aimed at people who have already tried standard cancer treatments, like chemotherapy, but their cancer has continued to grow or come back.

This research is important because it explores new ways to treat these difficult cancers. By understanding how safe and effective Lete-Cel is, doctors hope to offer more options to patients in the future. It's part of a larger research effort to find better treatments for cancer using the body's own immune system.

Key takeaways

  • This study is testing a new cell therapy (Lete-Cel) for advanced synovial sarcoma and myxoid/round cell liposarcoma.
  • It's for people whose cancer hasn't responded to previous standard treatments.
  • The treatment involves using your own specially modified immune cells to fight the cancer.
  • You would need to meet specific health and cancer criteria to be eligible.
  • Participation involves cell collection, potential chemotherapy, and regular follow-up appointments.
  • You can stop participating in the study at any time.

Who may be eligible?

To join this study, you would need to meet certain requirements. Firstly, you must be at least 10 years old and weigh 40 kilograms (about 6 stone 4 pounds) or more. You need to have a confirmed diagnosis of synovial sarcoma or myxoid/round cell liposarcoma, and your cancer must be advanced, meaning it has spread or can't be removed by surgery without major health risks. Your medical team would also need to confirm that your cancer has certain specific genetic changes. This includes a particular genetic marker called HLA-A2 and another one called NY-ESO-1 on your cancer cells.

You would also need to have tried at least one standard treatment for your advanced cancer, such as certain types of chemotherapy like doxorubicin, which hasn't worked or you couldn't tolerate. Your doctor would assess your general health and confirm that you are expected to live for at least another 24 weeks. This study is open to both men and women, but if you are able to have children, specific contraception rules would apply during treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you at least 10 years old and weigh 40kg (about 6 stone 4 pounds) or more?
  2. Do you have advanced synovial sarcoma or myxoid/round cell liposarcoma?
  3. Has your cancer been previously treated but has either come back or not responded?
  4. Does your cancer have specific markers (HLA-A2 and NY-ESO-1) that the study treatment targets?
  5. Do you have a general good health and an expected life expectancy of at least 24 weeks?
Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step is called 'leukapheresis'. This is a procedure similar to donating blood, where some of your blood is taken, and your immune cells (T-cells) are separated out. These T-cells are then sent to a lab to be specially prepared and 'trained' to fight your cancer. While your cells are being prepared, you might receive some short courses of chemotherapy, such as Cyclophosphamide and Fludarabine, to help make space for the new, engineered T-cells in your body.

Once your T-cells are ready, they will be given back to you through an infusion, like a drip. After the treatment, you will have regular check-ups and tests with the study team to see how you are doing, how the treatment is affecting your cancer, and to monitor for any side effects. These check-ups will continue over time and could include blood tests, scans, and physical examinations. The total length of your participation would depend on your response to the treatment and the study plan, but you would be monitored closely for many months.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. You might benefit from receiving a new and experimental treatment that is not yet widely available, which could help slow down or shrink your cancer, though this is not guaranteed. However, there are also risks, including side effects from the chemotherapy and the Lete-Cel treatment itself. These could range from mild to severe, and the study team will carefully explain all known and potential side effects to you. You will be closely monitored throughout the study to manage any side effects. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (38)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • City of Hope National Medical Center
    Verified postcode
    Duarte, United States
  • Stanford Hospital and Clinics
    Verified postcode
    Stanford, United States
  • Sarah Cannon Research Institute
    Verified postcode
    Denver, United States
  • Mayo Clinic Jacksonville
    Verified postcode
    Jacksonville, United States
  • University of Chicago
    Verified postcode
    Chicago, United States
  • University of Iowa College of Medicine
    Verified postcode
    Iowa City, United States
  • Dana Farber Cancer Institute
    Verified postcode
    Boston, United States
  • Massachusetts General Hospital
    Verified postcode
    Boston, United States
  • University of Michigan Medical Center
    Verified postcode
    Ann Arbor, United States
  • Minnesota Oncology Hematology
    Verified postcode
    Minneapolis, United States
  • Mayo Clinic Rochester
    Verified postcode
    Rochester, United States
  • Washington University
    Verified postcode
    St Louis, United States

Common questions

What is Lete-Cel?

Lete-Cel is an experimental cell therapy that uses your own immune cells, specially modified to target and fight your cancer.

What types of cancer is this study for?

This study is for advanced (spread or inoperable) synovial sarcoma or myxoid/round cell liposarcoma.

Do I have to have had other treatments first?

Yes, you must have tried at least one standard treatment for your advanced cancer that hasn't been effective or you couldn't tolerate.

Will I need to have my blood taken?

Yes, you'll have a procedure called leukapheresis to collect your immune cells, and regular blood tests for monitoring.

Can I stop participating in the study if I want to?

Absolutely, you can decide to leave the study at any point without it affecting your future medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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