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

Running, not enrolling · Phase 2

Conditions studied: Neoplasms

In brief

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.

Key facts

Study ID

NCT05993299

Run by

USWM, LLC (dba US WorldMeds)

People needed

7

Starts

2019-12-31

Expected to finish

2026-07-01

Last updated by the study team

2026-04-08

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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