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
NCT ID: NCT05993299
Last Updated: 2024-10-22
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
7 participants
INTERVENTIONAL
2019-12-31
2025-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Letetresgene autoleucel
Letetresgene autoleucel
Letetresgene autoleucel will be administered.
Cyclophosphamide
Cyclophosphamide will be used as a lymphodepleting chemotherapy.
Fludarabine
Fludarabine will be used as a lymphodepleting chemotherapy.
Interventions
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Letetresgene autoleucel
Letetresgene autoleucel will be administered.
Cyclophosphamide
Cyclophosphamide will be used as a lymphodepleting chemotherapy.
Fludarabine
Fludarabine will be used as a lymphodepleting chemotherapy.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
10 Years
ALL
No
Sponsors
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Adaptimmune
INDUSTRY
Responsible Party
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Locations
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City of Hope National Medical Center
Duarte, California, United States
Stanford Hospital and Clinics
Stanford, California, United States
Sarah Cannon Research Institute
Denver, Colorado, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
University of Chicago
Chicago, Illinois, United States
University of Iowa College of Medicine
Iowa City, Iowa, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Minnesota Oncology Hematology
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Memorial Sloan Kettering cancer center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Ohio State University-Columbus
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pittsburgh, Hillman Cancer centre
Pittsburgh, Pennsylvania, United States
Tennessee Oncology
Nashville, Tennessee, United States
University Of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Froedtert Hospital
Milwaukee, Wisconsin, United States
CIUSSS de L'Est-De-Lile-De-Montreal
Montreal, Quebec, Canada
Princess Margaret Cancer Centre
Toronto, , Canada
Centre Léon Bérard
Lyon, , France
CHU de Bordeaux GH Sud Hôpital Haut Lévêque
Pessac, , France
Fondazione IRCCS Instituto Nazionale Dei Tumori
Milan, , Italy
Ircss Istituto Clinico Humanitas
Romano di Lombardia, , Italy
The Netherlands Cancer Institute
Amsterdam, , Netherlands
Hospital Santa Creu Y Sant Pau
Barcelona, , Spain
Ico Duran y Reynals l'Hospitalet de Llobrega
Hospitalet de Llobregat, Barcelona, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Virgen Del Rocio
Seville, , Spain
Royal Marsden Hospital
London, , United Kingdom
University College Hospital-London
London, , United Kingdom
Christie Hospital NHS Foundation Trust
Manchester, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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208467 Substudy 1
Identifier Type: -
Identifier Source: org_study_id
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