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NCT05993299CompletedPhase 2

Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma

Evaluation of Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma

Source: ClinicalTrials.gov · Last updated 2 Sept 2026

Brief summary (registry, in English)

This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors. This trial is a sub study of the Master study NCT03967223.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
7 (actual)
First submitted
7 Aug 2023
Start date
31 Dec 2019
Primary completion date
12 Oct 2022
Lead sponsor
USWM, LLC (dba US WorldMeds)
NCT number
NCT05993299

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 7
  • From 31 Dec 2019 to the primary completion date, 12 Oct 2022
  • 37 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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)

Other

  • Central nervous system metastases.

Who the study is looking for

  • 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.

Age in the registry: 10 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (37)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CIUSSS de L'Est-De-Lile-De-Montreal
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MontrealCanadaUnknown status
Princess Margaret Cancer Centre
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TorontoCanadaUnknown status
Hospital Santa Creu Y Sant Pau
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BarcelonaSpainUnknown status
Ico Duran y Reynals l'Hospitalet de Llobrega
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Hospitalet de Llobregat, BarcelonaSpainUnknown status
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainUnknown status
Hospital Virgen Del Rocio
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SevilleSpainUnknown status
Centre Leon Berard
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LyonFranceUnknown status
CHU de Bordeaux GH Sud Hôpital Haut Lévêque
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PessacFranceUnknown status
University College Hospital - London
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LondonUnited KingdomUnknown status
Royal Marsden Hospital
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LondonUnited KingdomUnknown status
Christie Hospital NHS Foundation Trust
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ManchesterUnited KingdomUnknown status
Fondazione IRCCS Instituto Nazionale dei Tumori
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MilanItalyUnknown status
Ircss Istituto Clinico Humanitas
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Romano di LombardiaItalyUnknown status
The Netherlands Cancer Institute
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AmsterdamNetherlandsUnknown status
University of Michigan Medical Center
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Ann ArborUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
University of Chicago
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ChicagoUnited StatesUnknown status
Ohio State University-Columbus
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ColumbusUnited StatesUnknown status
University of Texas Southwestern Medical Center
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DallasUnited StatesUnknown status
Sarah Cannon Research Institute
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DenverUnited StatesUnknown status
City of Hope National Medical Center
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DuarteUnited StatesUnknown status
Duke University Medical Center
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DurhamUnited StatesUnknown status
University of Iowa College of Medicine
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Iowa CityUnited StatesUnknown status
Mayo Clinic- Jacksonville
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JacksonvilleUnited StatesUnknown status
Froedtert Hospital
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MilwaukeeUnited StatesUnknown status
Minnesota Oncology Hematology
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MinneapolisUnited StatesUnknown status
Tennessee Oncology
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NashvilleUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
University of Pittsburgh, Hillman Cancer Centre
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PittsburghUnited StatesUnknown status
Oregon Health and Science University
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PortlandUnited StatesUnknown status
Virginia Commonwealth University
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RichmondUnited StatesUnknown status
Mayo Clinic - Rochester
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RochesterUnited StatesUnknown status
University of Utah
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Salt Lake CityUnited StatesUnknown status
Fred Hutchinson Cancer Research Center
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SeattleUnited StatesUnknown status
Stanford Hospital and Clinics
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StanfordUnited StatesUnknown status
Washington University
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St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.