Active not recruitingPHASE2INTERVENTIONAL

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

This research study is investigating a new type of treatment called Lete-Cel, which is a T-cell therapy. T-cells are part of your immune system that can fight disease. The study is for people aged 10 and over who have advanced synovial sarcoma or myxoid/round cell liposarcoma, two types of cancer that haven't been treated before. Researchers want to understand if Lete-Cel is safe and if it can help stop the cancer from growing. This is a Phase 2 study, meaning it's still an early stage of testing, and it involves closely monitoring participants to see how they respond to the treatment and to identify any side effects. It's a key step in developing new ways to treat these specific cancers.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

USWM, LLC (dba US WorldMeds)

Enrolment target

Start

31 Dec 2019

Estimated completion

01 Jul 2026

Neoplasms

What is this study about?

This study is looking at a new and hopeful treatment for people with certain types of cancer: synovial sarcoma and myxoid/round cell liposarcoma. These are cancers that are considered 'advanced', meaning they may have spread or cannot be removed by surgery. The treatment being tested is called Lete-Cel, which uses your body's own immune cells, called T-cells, to fight the cancer. The idea is to take some of your T-cells, change them in a laboratory to make them better at finding and attacking cancer cells that have a specific marker called NY-ESO-1, and then give them back to you.

Before you receive the Lete-Cel treatment, you might also be given two other medicines, cyclophosphamide and fludarabine. These are used to prepare your body to receive the new T-cells, making sure they have the best chance to work effectively. The main goals of this study are to find out if this treatment is safe for people with these cancers and how well it works to shrink or stop the growth of the tumours.

Being part of a study like this means you would be among the first people to receive this new treatment in a controlled setting. It's an important step in learning more about how to fight these specific cancers, and the information gathered will help doctors understand if Lete-Cel could become a standard treatment option in the future. Remember, it's a research study, and while there's hope for new treatments, it's not guaranteed to work for everyone.

Key takeaways

This study investigates a new T-cell therapy (Lete-Cel) for specific advanced cancers.
It aims to check the safety and effectiveness of Lete-Cel.
Participants must be at least 10 years old and have certain cancer types and markers.
The treatment involves taking your T-cells, modifying them, and giving them back.
Regular hospital visits and monitoring are part of the study.
You can stop participating at any time without affecting your care.

Who may be eligible?

To join this study, people generally need to be at least 10 years old and weigh at least 40 kg. Your cancer must be either synovial sarcoma or myxoid/round cell liposarcoma, and special tests will be done to check if your body's immune system markers (called HLA-A) and your cancer cells' markers (NY-ESO-1) match what is needed for this specific treatment. You will also need to be in good overall health, with your organs like your heart, lungs, and kidneys working well.

There are also some reasons why you wouldn't be able to join. For example, if your cancer has spread to your brain or spinal cord, or if you have had other cancers that are not fully healed. You also can't have serious ongoing infections or certain severe heart, lung, or liver problems. If you've had certain immune diseases that require strong medications, or if you've had similar gene-based therapies or transplants in the past, you would also not be able to take part.

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.

Are you at least 10 years old and weigh 40 kg or more?
Do you have synovial sarcoma or myxoid/round cell liposarcoma?
Has your cancer not been treated before with specific gene therapies or NY-ESO-1 treatments?
Are you generally well, with your main organs (heart, lungs, kidneys) working properly?
Do you not have cancer spread to your brain or spinal cord?
Do you not have severe active infections or certain serious autoimmune diseases?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve several steps. First, you'd go through screening tests to make sure you're a good fit. If you qualify, some of your blood would be collected in a process called 'leukapheresis' – similar to donating blood, but only white blood cells are taken – to gather your T-cells. These T-cells would then be sent to a lab to be specially prepared. Before receiving the modified T-cells, you would have a short course of chemotherapy medicines (cyclophosphamide and fludarabine). Then, you would receive the Lete-Cel infusion.

Throughout the study, you would have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working. This is to keep a close eye on any side effects and to see if the tumour is shrinking. The total duration of your participation and follow-up would be discussed in detail by the study team, and it involves monitoring your health for an extended period after treatment.

Potential risks and benefits

Taking part in a clinical trial like this offers the potential benefit of accessing a new, investigational treatment for your cancer that is not yet widely available. While we hope the treatment helps, it's important to understand that it may not work for everyone, and there's also the chance it may not improve your cancer. Like all medical treatments, there are potential risks and side effects from the medications and procedures involved, which the study team will explain in detail. These can range from mild to serious, and your health will be closely monitored. You always have the right to withdraw from the study at any time, for any reason, without it affecting your future 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 a new treatment that uses your own immune cells (T-cells) to find and fight cancer cells. It's a type of 'T-cell therapy'.

What types of cancer is this study for?

This study is for people with advanced synovial sarcoma or myxoid/round cell liposarcoma that haven't been treated before.

Will I have to stay in the hospital a lot?

You will have regular hospital visits for important tests and monitoring, especially around the time you receive the treatment. The team will tell you the exact schedule.

Are there any other medicines involved?

Yes, you might receive other medicines called cyclophosphamide and fludarabine to prepare your body before you get the Lete-Cel treatment.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect any future medical care you receive.