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Designer immune cells take on rare sarcomas

NCT ID NCT05993299

Disease control Sponsor: USWM, LLC (dba US WorldMeds) 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Updated 2 times

Summary

This phase 2 trial tests a personalized cell therapy called Lete-Cel in 7 people with advanced synovial sarcoma or myxoid/round cell liposarcoma that has not been treated before. Participants receive their own immune cells that have been engineered to recognize and attack their cancer, along with chemotherapy to prepare the body. The main goal is to see if the tumors shrink or disappear.

What this could mean

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

Active substance
Letetresgene autoleucel (engineered immune cells) given with chemotherapy drugs cyclophosphamide and fludarabine
What this could lead to
If it works, this could offer a new treatment option for people with certain advanced sarcomas that have few other choices.
What could go wrong
This is a very small, early-phase trial with only 7 participants. The therapy may not shrink tumors or could cause serious side effects from the chemotherapy or cell infusion.

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

7 people

The number who actually took part.

Started

Dec 2019

Finished

Mar 2026

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 years and older

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.

Inclusion Criteria: * Participant must be greater than or equal to 10 years of age on the day of signing informed consent. * Participant scheduled to receive clinical drug product supply must also weigh ≥40 kg * Participant must be positive for HLA-A\*02:01, HLA-A\*02:05, and/or HLA-A\*02:06 alleles by a designated central laboratory * Participant's tumor is positive for NY-ESO-1 expression by a designated central laboratory. * Participant has a diagnosis of synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCLS) * Performance status: dependent on age - Lansky \> 60, Karnofsky \> 60, Eastern * Cooperative Oncology Group 0-1. * Participant must have adequate organ function and blood cell counts, within 7 days prior to leukapheresis. * At time of treatment, participant has measurable disease according to RECIST v1.1. * Male or female. Contraception requirements will apply at the time of leukapheresis and treatment. * Consultation for prior history per protocol specifications. Exclusion Criteria: * Central nervous system metastases. * Any other prior malignancy that is not in complete remission. * Clinically significant systemic illness (.(Serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction, that in the judgment of the Investigator would compromise the participant's ability to tolerate protocol therapy or significantly increase the risk of complications) * Prior or active demyelinating disease. * History of chronic or recurrent (within the last year prior to leukapheresis) severe autoimmune or immune mediated disease (e.g. Crohn's disease, systemic lupus) requiring steroids or other immunosuppressive treatments. * Previous treatment with genetically engineered NY-ESO-1-specific T cells. * Previous NY-ESO-1 vaccine or NY-ESO-1 targeting antibody. * Prior gene therapy using an integrating vector. * Previous allogeneic hematopoietic stem cell transplant. * Washout periods for prior radiotherapy and systemic chemotherapy must be followed. * Participant had major surgery in less than or equal to 28 days of first dose of study intervention. * Prior radiation exceeds protocol specified limits.

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Conditions

The condition(s) this trial relates to.

myxoid/round cell liposarcoma neoplasm synovial sarcoma

As listed by the trial registrant

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

Neoplasms

Contacts and locations

Locations

  • CHU de Bordeaux GH Sud Hôpital Haut Lévêque

    Pessac, 33604, France

  • CIUSSS de L'Est-De-Lile-De-Montreal

    Montreal, Quebec, H1T 2M4, Canada

  • Centre Léon Bérard

    Lyon, 69373, France

  • Christie Hospital NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02114, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Fondazione IRCCS Instituto Nazionale Dei Tumori

    Milan, 20133, Italy

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024, United States

  • Froedtert Hospital

    Milwaukee, Wisconsin, 53226, United States

  • Hospital Santa Creu Y Sant Pau

    Barcelona, 08025, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • Hospital Virgen Del Rocio

    Seville, 41013, Spain

  • Ico Duran y Reynals l'Hospitalet de Llobrega

    Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Ircss Istituto Clinico Humanitas

    Romano di Lombardia, 20089, Italy

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering cancer center

    New York, New York, 10065, United States

  • Minnesota Oncology Hematology

    Minneapolis, Minnesota, 55455, United States

  • Ohio State University-Columbus

    Columbus, Ohio, 43210, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Princess Margaret Cancer Centre

    Toronto, M5G 2M9, Canada

  • Royal Marsden Hospital

    London, SW3 6JJ, United Kingdom

  • Sarah Cannon Research Institute

    Denver, Colorado, 80218, United States

  • Stanford Hospital and Clinics

    Stanford, California, 94305, United States

  • Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • The Netherlands Cancer Institute

    Amsterdam, 1066 CX, Netherlands

  • University College Hospital-London

    London, WC1E 6AG, United Kingdom

  • University Of Texas Southwestern Medical Center

    Dallas, Texas, 75390-8565, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Iowa College of Medicine

    Iowa City, Iowa, 52242-1009, United States

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109, United States

  • University of Pittsburgh, Hillman Cancer centre

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-9063, United States

  • University of Utah

    Salt Lake City, Utah, 84112, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

  • Washington University

    St Louis, Missouri, 63110, United States

More trials for these conditions

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