Study on the Safety and Effectiveness of Lete-Cel for Treating Advanced Synovial Sarcoma and Myxoid/Round Cell Liposarcoma

Sponsor: USWM, LLC (dba US WorldMeds)

Sponsor score: 0

ClinicalTrials ID:NCT05993299

This clinical trial is testing a new treatment called Lete-Cel for patients with advanced synovial sarcoma or myxoid/round cell liposarcoma. The study aims to determine if this treatment is safe and effective in shrinking tumors in patients who have not received prior treatment for their cancer.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new treatment called Lete-Cel, which is a type of engineered T-cell therapy. This treatment is being tested in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma, which are types of cancer that have either spread or cannot be removed by surgery. The study is part of a larger research project and aims to see if Lete-Cel can help reduce tumors in these patients.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 10 years old.
  • Must weigh at least 40 kg if receiving the study drug.
  • Must have specific genetic markers (HLA-A02:01, HLA-A02:05, and/or HLA-A*02:06).
  • Tumor must test positive for NY-ESO-1.
  • Must have a diagnosis of synovial sarcoma or myxoid/round cell liposarcoma.
  • Must be in good general health with a performance status score above 60.
  • Must have adequate organ function and blood cell counts before starting treatment.
  • Must have measurable disease according to specific criteria.
  • Must agree to use contraception during the study.
  • Must meet specific health history requirements.

Exclusion Criteria

  • Cancer has spread to the brain or spinal cord.
  • Have another type of cancer that is not in complete remission.
  • Have a serious illness that could interfere with the study treatment.
  • Have a history of certain diseases affecting the nervous system.
  • Have a history of severe autoimmune diseases requiring treatment.
  • Have received previous treatments targeting NY-ESO-1.
  • Have had gene therapy or a stem cell transplant in the past.
  • Must follow specific waiting periods after previous cancer treatments.
  • Have had major surgery within 28 days before starting the study treatment.
  • Have received too much radiation in the past.

Locations

FACILITYZIPCITYSTATE
City of Hope National Medical Center91010DuarteCalifornia
Stanford Hospital and Clinics94305StanfordCalifornia
Sarah Cannon Research Institute80218DenverColorado
Mayo Clinic Jacksonville32224JacksonvilleFlorida
University of Chicago60637ChicagoIllinois
University of Iowa College of Medicine52242-1009Iowa CityIowa
Dana Farber Cancer Institute02114BostonMassachusetts
Massachusetts General Hospital02114BostonMassachusetts
University of Michigan Medical Center48109Ann ArborMichigan
Minnesota Oncology Hematology55455MinneapolisMinnesota

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