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Genetically modified t cells take on rare sarcomas

NCT ID NCT04044768

Disease control Sponsor: USWM CT, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This phase 2 trial tests a one-time infusion of a patient's own immune cells that have been genetically modified to recognize and attack cancer cells. It is for people with advanced synovial sarcoma or myxoid liposarcoma whose tumors have a specific marker (MAGE-A4) and who have already tried standard chemotherapy. The main goal is to see if the treatment shrinks tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
afamitresgene autoleucel (ADP-A2M4) – a patient's own immune cells genetically modified to target cancer
What this could lead to
If successful, this could offer a new treatment option for people with advanced synovial sarcoma or myxoid liposarcoma who have few alternatives.
What could go wrong
This is a small, early-phase trial (52 participants) with no control group. The treatment may cause serious side effects, and it is not yet proven to work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

52 people

The number who actually took part.

Started

Aug 2019

Expected to finish

Apr 2038

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria * Age ≥16 (10 years at selected sites) and \<=75 years * Diagnosis of advanced synovial sarcoma (Cohort 1, Cohort 2 and Cohort 3) or myxoid liposarcoma / myxoid round cell liposarcoma (Cohort 1 only) confirmed by cytogenetics. * Previously received either an anthracycline or ifosfamide containing regimen. * Measurable disease according to RECIST v1.1 prior to lymphodepletion * HLA-A\*02:01, HLA-A\*02:02, HLA-A\*02:03 or HLA-A\*02:06 positive * Tumor shows MAGE-A4 expression confirmed by central laboratory. North America Only (United States and Canada): Tumor (either an archival specimen or a fresh biopsy) shows MAGE-A4 expression of ≥1+ staining in ≥10% of the cells by immunohistochemistry. * ECOG Performance Status of 0 or1. For subjects aged ≥10 to ≥16 years old: Lansky Score ≥60%. • Left ventricular ejection fraction (LVEF) ≥50%. Note: other protocol defined Inclusion criteria may apply Key Exclusion Criteria: * HLA-A\*02:05 in either allele * Received or plans to receive the following therapy/treatment prior to leukapheresis or lymphodepleting chemotherapy: Cytotoxic chemotherapy, Tyrosine kinase inhibitor (TKI) (e.g. pazopanib), Immune therapy (including monoclonal antibody therapy, checkpoint inhibitors,), Anti-cancer Vaccine, Gene therapy using an integrating vector (subjects who have received a gene therapy using a lentiviral vector may be eligible for the study), Corticosteroids or any other immunosuppressive therapy, Investigational treatment or interventional clinical trial, Allogeneic hematopoietic stem cell transplant, Radiotherapy to the target lesions, Major surgery * History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study. * History of autoimmune or immune mediated disease * Symptomatic CNS metastases including leptomeningeal disease. * Other prior malignancy that is not considered by the Investigator to be in complete remission * Clinically significant cardiovascular disease * Uncontrolled intercurrent illness * Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus * Pregnant or breastfeeding Note: other protocol defined Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

myxoid liposarcoma myxoid/round cell liposarcoma sarcoma synovial sarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myxoid liposarcoma Synovial sarcoma

Contacts and locations

Locations

  • Centre Leon Berard

    Lyon, France

  • City of Hope

    Duarte, California, 91010, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Fred Hutch

    Seattle, Washington, 98109, United States

  • Gustave Roussy Cancer Center

    Villejuif, 94805, France

  • Hospital Haut Leveque, CHU Bordeaux

    Pessac, 33604, France

  • Hospital Universitari Vall D'Hebron

    Barcelona, Catalonia, 119-129, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 33612, United States

  • Medical College of WI Froedtert Hospital

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • National Cancer Institute

    Bethesda, Maryland, 20892, United States

  • Northwestern University Robert H. Lurie Comprehensive Cancer Center

    Chicago, Illinois, 60611, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Stanford Cancer Center

    Palo Alto, California, 94305, United States

  • Start Madrid-FJD, Fundación Jimѐnez Díaz

    Madrid, 28040, Spain

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • UCLH Cancer Clinical Trials Unit

    London, NW1 2PG, United Kingdom

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Vanderbilt

    Nashville, Tennessee, 37212, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.