Study on the Safety and Effectiveness of Lete-Cel in Patients with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

Sponsor: USWM CT, LLC

Sponsor score: 0

ClinicalTrials ID:NCT06703346

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 evaluate the safety and effectiveness of this therapy in shrinking tumors in patients who have already received other treatments.

Patient Parameters

Program Overview

The purpose of this study is to assess the safety and effectiveness of a new treatment called Lete-Cel in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma. This treatment involves using specially engineered T-cells to target and attack cancer cells. The trial is part of a larger study and focuses on patients whose cancer has not responded to previous treatments or cannot be surgically removed.

Eligibility Criteria

Inclusion Criteria

  • Must be 10 years or older and weigh at least 40 kg if receiving the treatment.
  • Diagnosed with synovial sarcoma or myxoid/round cell liposarcoma, confirmed by specific lab tests.
  • Cancer must be advanced, meaning it has spread or cannot be removed by surgery.
  • Must have a life expectancy of at least 24 weeks.
  • Must have specific genetic markers related to the cancer type.
  • Must have previously received standard treatments for the cancer.
  • Must test positive for certain HLA markers.
  • Tumor must show a specific protein called NY-ESO-1.
  • Must have good heart function and overall health.
  • Must have adequate organ function and blood cell counts.
  • Must be able to undergo a procedure to collect blood cells.
  • Women of childbearing potential must have a negative pregnancy test.
  • Must have measurable disease and evidence of disease progression.
  • Must provide a tumor sample for analysis if possible.

Exclusion Criteria

  • Cancer has spread to the brain or spinal cord.
  • Have another cancer that is not in complete remission.
  • Have received previous treatments targeting NY-ESO-1.
  • Have had gene therapy or stem cell transplants.
  • Have serious health conditions that could affect treatment.
  • Have received certain cancer treatments or vaccines recently.
  • Have had major surgery recently.

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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