Study on Genetically Engineered T Cells for Treating Solid Tumors with NY-ESO-1 and/or LAGE-1a Proteins
Sponsor: Adaptimmune
ClinicalTrials ID:NCT03967223
This clinical trial is testing the safety and effectiveness of a new treatment using genetically engineered T cells to target specific proteins found in certain advanced solid tumors.
Patient Parameters
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Program Overview
This study is exploring a new treatment that uses specially engineered T cells to target proteins called NY-ESO-1 and LAGE-1a, which are found in some types of tumors. The trial aims to determine if this approach is safe and can help shrink tumors in patients with advanced cancers. The study includes two parts: one for patients who have not yet received treatment for their cancer, and another for those whose cancer has returned or progressed after initial chemotherapy.
Description
Researchers are testing a new therapy that uses genetically engineered T cells to target specific proteins, NY-ESO-1 and LAGE-1a, found in certain tumors. These proteins are associated with cancers like synovial sarcoma and myxoid/round cell liposarcoma. The treatment, called Letetresgene autoleucel (lete-cel), is designed to help the immune system recognize and attack cancer cells.
The study is divided into two parts. The first part involves patients who have not yet received treatment for their cancer, while the second part includes those whose cancer has returned or progressed after chemotherapy. Participants must have specific genetic markers (HLA-A*02+) and their tumors must express the NY-ESO-1 protein. The trial will assess the safety and effectiveness of this new treatment approach.
Eligibility Criteria
Inclusion Criteria
- Must be 10 years or older.
- Must weigh at least 40 kg if receiving the treatment.
- Must have specific genetic markers (HLA-A02:01, HLA-A02:05, and/or HLA-A*02:06).
- Tumor must express the NY-ESO-1 protein.
- Diagnosed with 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 treatment.
- Must have measurable disease according to standard criteria.
- Must agree to use contraception during treatment.
- Must meet specific health and treatment history requirements.
Exclusion Criteria
- Cancer has spread to the brain or spinal cord.
- Any other cancer that is not in complete remission.
- Serious health conditions that could affect treatment safety.
- History of certain immune system diseases.
- Previous treatment with similar genetically engineered T cells.
- Previous NY-ESO-1 vaccine or antibody treatment.
- Previous gene therapy using certain vectors.
- Previous stem cell transplant from a donor.
- Must follow specific waiting periods after previous treatments.
- Recent major surgery within 28 days before starting the study.
- Previous radiation treatment exceeding study limits.
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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