Active not recruitingPHASE2INTERVENTIONAL

Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumors

This study is investigating a new type of treatment for certain advanced cancers, specifically synovial sarcoma and myxoid/round cell liposarcoma. The treatment, called lete-cel, uses your own immune cells that have been specially modified in a lab to recognise and fight cancer cells that have certain markers called NY-ESO-1 and/or LAGE-1a. Researchers want to find out how safe this treatment is and how well it works. They will be looking at people who are receiving this treatment for the first time, as well as those who have already had other treatments. The study is particularly for people whose cancer has these specific markers and who also have a particular genetic type known as HLA-A*02.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

USWM CT, LLC

Enrolment target

103

Start

31 Dec 2019

Estimated completion

31 Jul 2026

Neoplasms

What is this study about?

This research study is trying out a new way to treat certain advanced cancers, including synovial sarcoma and myxoid/round cell liposarcoma. These are types of soft tissue cancers. The new treatment, called lete-cel (pronounced leh-tee-sell), works by using your body's own immune system.

Here’s how it works: Some cancer cells have special markers on their surface, like tiny flags, called NY-ESO-1 and LAGE-1a. This new treatment takes some of your immune cells (called T-cells) and changes them in a laboratory so they can specifically recognise and attack cancer cells that have these markers. Think of it like training your immune cells to become super-soldiers that specifically target the cancer.

The main goal of this study is to see how safe this new treatment is and how well it helps control the cancer. The study will look at two main groups of people: those who are getting this treatment for the first time, and those whose cancer has returned or progressed after other types of treatment, such as chemotherapy. It’s important to know that this treatment is only for people whose cancer cells have the NY-ESO-1 marker and who also have a specific genetic type called HLA-A*02.

Key takeaways

This study explores a new immune cell therapy for specific advanced sarcomas.
The treatment, lete-cel, uses your own modified immune cells to target cancer.
It's for people with NY-ESO-1 positive cancer and a specific HLA-A*02 genetic type.
The study aims to check the safety and effectiveness of this new approach.
Participation involves cell collection, pre-treatment medication, and close monitoring.

Who may be eligible?

To be considered for this study, you need to be at least 10 years old and weigh at least 40 kg (about 6 stone 4 pounds). Your cancer must be either synovial sarcoma or myxoid/round cell liposarcoma, and your cancer cells need to show a specific marker called NY-ESO-1. You also need to have a particular genetic feature called HLA-A*02, which will be checked by a special lab. Your general health must be good enough for you to take part, meaning your organs like your heart, lungs, and liver are working well, and your blood counts are within a healthy range.

There are some reasons why you might not be able to join. For example, if your cancer has spread to your brain or spinal cord, or if you have had other types of cancer that haven't been completely cured. You also can't have serious active infections, significant heart or lung problems, or certain autoimmune diseases that affect your immune system. If you've had a bone marrow transplant in the past, or if you've already had treatments using similar genetically modified cells or certain NY-ESO-1 targeting therapies, you won't be able to join this particular study.

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 over 40kg?
Do you have synovial sarcoma or myxoid/round cell liposarcoma?
Has your doctor confirmed your cancer has the NY-ESO-1 marker?
Are your general health and organ functions considered good?
Have you not had cancer spread to your brain or spinal cord?
Have you NOT had certain previous immune-modifying treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step is usually a process called leukapheresis. This is where blood is drawn from your arm, special machines separate out your immune cells, and then the rest of the blood is returned to your body. These collected immune cells are then sent to a lab to be specially modified. Before the main treatment, you will likely receive some medicines (fludarabine and cyclophosphamide) to prepare your body for the new cells. After receiving the special cells, you will have regular check-ups and tests to see how you are doing, how the treatment is affecting your cancer, and to monitor for any side effects. The study involves several hospital visits for treatments and follow-up appointments, but the exact number and duration will be explained by the study team.

Potential risks and benefits

Taking part in this study could offer you access to a new treatment that might help control your advanced cancer, especially if other treatments haven't worked or are not suitable. However, as with all medical treatments, there are potential risks and side effects that your doctors will discuss with you. These could be related to the preparing medicines or the new immune cells themselves. You will be closely monitored for any adverse effects. Remember, joining a clinical study is completely voluntary, and you have the right to withdraw at any time without explanaion, and this will not affect 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, specially trained to fight cancer cells with certain markers called NY-ESO-1.

What kind of cancers is this study for?

This study is for people with advanced synovial sarcoma or myxoid/round cell liposarcoma.

What do NY-ESO-1 and HLA-A*02 mean?

NY-ESO-1 is a specific marker on cancer cells, and HLA-A*02 is a type of genetic feature you need to have for this treatment to work.

Will I have to stay in hospital?

You will likely have several hospital visits for treatment and follow-up, and the study team will explain the details of the schedule.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without giving a reason, and it won't affect your future medical care.