Engineered immune cells take on rare sarcomas in new trial

NCT ID NCT06703346

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

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This phase 2 trial tests a treatment called Lete-Cel, which uses a patient's own immune cells that have been specially trained to attack cancer cells. It is for people with advanced synovial sarcoma or myxoid/round cell liposarcoma whose tumors have a specific marker (NY-ESO-1) and who have already tried other treatments. The study aims to see if the therapy can shrink tumors and how safe it is.

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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

82 people

The number who actually took part.

Started

Dec 2019

Finished

Jul 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 ≥10 years of age at the time of signing the informed consent. * Participant scheduled to receive clinical drug product supply must also weigh ≥40 kg. * Participant has a diagnosis of synovial sarcoma or myxoid/round cell liposarcoma, confirmed by local histopathology with evidence of disease-specific translocation. * Participant has advanced (metastatic or unresectable) synovial sarcoma or myxoid/round cell liposarcoma. Unresectable refers to a tumor lesion in which clear surgical excision margins cannot be obtained without leading to significant functional compromise. * Male or female. Contraception requirements will apply at the time of leukapharesis and treatment. * Life expectancy ≥24 weeks * Participant has confirmed evidence of a relevant disease-specific translocation per below: * For synovial sarcoma, presence of a translocation involving chromosome 18 (SYT gene) and/or chromosome X (SSX1, SSX2 or SSX4 genes). * For myxoid/round cell liposarcoma, presence of a translocation involving chromosome 12 (DDIT3 gene) and/or chromosome 16 (FUS gene) and/or chromosome 22 (EWSR1 gene). * Participant is either currently being treated with or has completed at least one standard-of-care treatment including anthracycline-containing regimens (e.g., doxorubicin alone, doxorubicin with ifosfamide) for advanced (metastatic or inoperable) disease. Participants who are intolerant to anthracycline may receive ifosfamide alone unless intolerant to or ineligible to receive ifosfamide. Participants who received anthracycline-based therapy in the neoadjuvant/adjuvant setting and progressed will be eligible. * Participant must be positive for HLA-A\*02:01, HLA-A\*02:05, and/or HLA-A\*02:06 alleles by a validated test in a designated central lab prior to leukapheresis * Participant's tumor has been pathologically reviewed by a designated central laboratory with confirmed positive NY-ESO-1 expression defined as ≥30% of cells that are 2+ or 3+ by immunohistochemistry. * Left ventricular ejection fraction ≥45% with no evidence of clinically significant pericardial effusion. * Performance status: for participants \<16 years of age, Lansky \>60, or for participants ≥16 and \<18 years of age, Karnofsky \>60, or for participants ≥18 years of age, Eastern Cooperative Oncology Group (ECOG) of 0-1. * Participant must have adequate organ function and blood cell counts, within 7 days prior to the day of the leukapheresis procedure * Participant is fit for leukapheresis and has adequate venous access for the cell collection * Female participants of childbearing potential (FCBP) must have a negative urine or serum pregnancy test. * Participant has measurable disease according to RECIST v1.1. * Participant has documented radiographic evidence of disease progression from prior line of therapy. * A biopsy (excisional, incisional, or core) of non-target tumor tissue obtained within 28 days prior to initiating lymphodepleting chemotherapy is mandatory if clinically feasible. This biopsy will be used as baseline for biomarker analyses. If it is not feasible to obtain a fresh biopsy, an archival tumor tissue (FFPE block) taken preferably after completion of the participant's last line of therapy, preferably within 90 days prior to initiating lymphodepleting chemotherapy, may be accepted. * A haematologist has been consulted prior to lymphodepletion in participants who have had a serious/significant bleeding/thrombosis history. Exclusion Criteria: * Central nervous system (CNS) metastases. * Any other prior malignancy that is not in complete remission. * 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 * 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) or prior or active demyelinating disease * Participant has received cytotoxic therapy within 3 weeks prior to lymphodepleting chemotherapy * Systemic corticosteroids or any other immunosuppressive therapy within 2 weeks prior to lymphodepleting chemotherapy. * Participant has received ≥50 Gy to a significant volume of the pelvis, long bones or spine, or a cumulative dose of radiation that, in the Investigator's opinion would predispose patients to prolonged cytopenia after lymphodepletion. * All of the participant's measurable lesions have been irradiated within 3 months prior to lymphodepletion. An irradiated measurable lesion with unequivocal progression following irradiation may be considered a target lesion regardless of time from last radiotherapy dose. * Participant has received an anti-cancer vaccine within 2 months in the absence of tumor response. The participant should be excluded if their disease is responding to an experimental vaccine given within 6 months. * Participant has received live vaccine within 4 weeks prior to lymphodepletion or intends to receive live vaccine during the 3-month period following administration of lete-cel. * Participant has received immune therapy (monoclonal antibody therapy, checkpoint inhibitors) within 4 weeks of lymphodepletion. * Participant had major surgery ≥28 days of first dose of study intervention

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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, Lombardy, 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

Barcelona, 08907, Spain
Ircss Istituto Clinico Humanitas

Rozzano (MI), Lombardy, 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, Ontario, M5G 2M9, Canada
Royal Marsden Hospital

London, SW3 6JJ, United Kingdom
Sarah Cannon Research Institute

Denver, Colorado, 80218, United States
Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States
Stanford Hospital and Clinics

Stanford, California, 94305, 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

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