Study on the Safety and Effectiveness of Lete-Cel in Patients with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
Sponsor: USWM CT, LLC
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
| Parameter | Options |
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope National Medical Center | 91010 | Duarte | California |
| Stanford Hospital and Clinics | 94305 | Stanford | California |
| Sarah Cannon Research Institute | 80218 | Denver | Colorado |
| Mayo Clinic Jacksonville | 32224 | Jacksonville | Florida |
| University of Chicago | 60637 | Chicago | Illinois |
| University of Iowa College of Medicine | 52242-1009 | Iowa City | Iowa |
| Dana Farber Cancer Institute | 02114 | Boston | Massachusetts |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| University of Michigan Medical Center | 48109 | Ann Arbor | Michigan |
| Minnesota Oncology Hematology | 55455 | Minneapolis | Minnesota |
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