Active not recruitingPHASE1INTERVENTIONAL

MAGE-A4ᶜ¹º³²T for Multi-Tumor

This research study is looking at a new type of cell treatment called MAGE-A4ᶜ¹º³²T for several types of cancer, including bladder, melanoma, head and neck, ovarian, lung, oesophageal, stomach, and certain soft tissue cancers (synovial sarcoma, myxoid/round cell liposarcoma). The main goal is to find out if this treatment is safe and what side effects it might cause. Before taking part, people need to have a specific marker in their blood (HLA-A2) and their cancer cells must show a particular protein called MAGE-A4. The treatment involves taking a sample of your own immune cells (T-cells), changing them in a lab so they can recognise and fight cancer cells, and then giving them back to you. There's also a small part of the study where some people will receive this cell therapy along with a small amount of radiation.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

USWM CT, LLC

Enrolment target

Start

15 May 2017

Estimated completion

01 Sep 2032

Urinary Bladder Cancer Melanoma Head and Neck Cancer Ovarian Cancer Non-Small Cell Lung Cancer Esophageal Cancer Gastric Cancer Synovial Sarcoma Myxoid Round Cell Liposarcoma Gastroesophageal Junction

Results

Results from this study

Posted May 2026

Results have been published for this study.

Primary outcome

Adverse Events (AE) Including Serious Adverse Events (SAE)

An AE was defined as any untoward medical occurrence in a clinical study participant who received a pharmaceutical product, regardless of causality. An AE was , therefore, any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with AEs (including SAEs) are presented.

Full results on the registry

What is this study about?

This study is exploring a new way to fight certain advanced cancers. These include cancers of the bladder, skin (melanoma), head and neck, ovaries, lungs (non-small cell), oesophagus, stomach, and some rare soft tissue cancers like synovial sarcoma and myxoid/round cell liposarcoma.

Imagine your body's immune system as an army that fights off invaders. Our T-cells are like soldiers. For this treatment, doctors take some of your own T-cells and 're-programme' them in the lab. They give these cells a special ability to recognise and attack cancer cells that have a specific marker called MAGE-A4. Once these "super-soldiers" are ready, they're given back to you through an infusion, hoping they will find and destroy the cancer.

The main purpose of this early-stage study (Phase 1) is to check if this new cell therapy is safe for patients and how well their bodies tolerate it. It's a bit like testing a new car model to make sure it handles well and is reliable. There's also a small group of people in the study who will receive this new cell therapy alongside a low dose of radiation, to see if combining these treatments is also safe and tolerable.

Key takeaways

This is an early-stage study (Phase 1) focused on safety.
It uses your own modified immune cells to fight cancer.
Only for specific cancer types with the MAGE-A4 target protein.
A small group will also receive low-dose radiation.
Requires specific blood markers (HLA-A*02) to participate.
You will have regular hospital visits and long-term follow-up.

Who may be eligible?

To join this study, you generally need to be between 18 and 75 years old and have one of the specific cancer types mentioned. A key requirement is that your cancer cells must have a protein called MAGE-A4, and you must have a specific blood marker (HLA-A*02 positive) that helps the treatment work. Your organs also need to be working well, and your cancer should be measurable, meaning doctors can track its size.

There are also reasons why you might not be able to join. For example, if you have other serious health problems, certain infections like HIV or hepatitis, or if you are pregnant or breastfeeding. If your cancer has spread to your brain and is causing symptoms, or if your overall health isn't strong enough for the treatment, you wouldn't be able to participate.

For the small group also receiving radiation, you would need to have specific areas of your cancer that can be targeted safely with radiation. Also, if you've had certain types of radiation therapy recently, you wouldn't be eligible for this part of the 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 between 18 and 75 years old?
Do you have one of the listed cancer types?
Does your cancer have the MAGE-A4 protein?
Do you have the HLA-A*02 blood marker?
Are your organs generally healthy and working well?
Are you able to manage regular hospital visits and follow-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first go through screening tests to see if you're a good fit, such as blood tests for specific markers and checks on your general health. If you qualify, your T-cells will be collected, which is a process similar to donating blood, called leukapheresis. These cells will then be sent to a lab to be specially prepared. Before you receive the modified cells, you'll likely have a short course of chemotherapy to make space for the new cells.

The modified cells will be given to you through an IV drip. You'll need to stay in the hospital for a period after the infusion so doctors can closely monitor you for any side effects. You'll then have several follow-up appointments and tests over a longer period, possibly for many years, to check your health and how the treatment is working. The study is designed to carefully track your progress and safety.

Potential risks and benefits

This is an early-stage study, so it's important to understand that the main goal is to find out if the treatment is safe, not necessarily to cure your cancer. Potential benefits might include your cancer shrinking or slowing its growth, or a chance to try a new treatment when standard options haven't worked. However, there's no guarantee the treatment will work for you. Like all medical treatments, there are potential risks and side effects. These could be related to the chemotherapy given before the cell infusion, the cell infusion itself (such as reactions during the infusion or immune-related side effects), or the radiation therapy if you are in that group. The medical team will explain all known and potential risks in detail. Remember, you can choose to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (11)

University of Miami
Verified postcode
Miami, United States
Moffitt Cancer Center
Verified postcode
Tampa, United States
Washington University School of Medicine
Verified postcode
St Louis, United States
Washington University
Verified postcode
St Louis, United States
Roswell Park Cancer Institute
Verified postcode
Buffalo, United States
Duke University Medical Center, Duke Cancer Institute
Verified postcode
Durham, United States
Ohio State University Wexner Medical Center
Verified postcode
Columbus, United States
Fox Chase Cancer Center
Verified postcode
Philadelphia, United States
Tennessee Oncology - Sarah Cannon Research Institute
Verified postcode
Nashville, United States
M.D. Anderson Cancer Center
Verified postcode
Houston, United States
Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada

Common questions

What is MAGE-A4 and why is it important for this study?

MAGE-A4 is a protein found on the surface of some cancer cells, but not usually on healthy cells. For this study, it's like a special 'target' that the modified immune cells are trained to recognise and attack.

What are 'T-cells' and how are they used in this treatment?

T-cells are a type of white blood cell, a vital part of your immune system that fights infections and diseases like cancer. In this study, your own T-cells are collected, modified in a lab to better recognise your cancer, and then given back to you.

What does a 'Phase 1' study mean?

Phase 1 is the first stage of testing a new treatment in people. The main aim is to make sure the treatment is safe, find the right dose, and understand any side effects, rather than primarily looking for a cure.

Will I have to stay in the hospital?

Yes, you will likely need to be in the hospital for the cell collection, for a short period before the treatment for any pre-treatment, and for monitoring after you receive the modified cells. There will also be many follow-up visits.

Can I still receive my other cancer treatments while on this study?

Certain other cancer treatments are not allowed during this study. The study team will review your current and past medications and treatments to make sure there are no conflicts.