A Test to See If You Qualify for a New Personalized Cancer Treatment Study
Screening Study to Determine HLA Type, HLA Loss of Heterozygosity Status and Tumor Antigen Expression in Participants With Locally Advanced (Unresectable) or Metastatic Solid Tumors
In Plain English
This is a screening study—not a treatment study. TScan Therapeutics is developing a new type of cancer therapy that uses your own immune cells, specially trained to recognize and attack your specific cancer. But this therapy only works for certain patients, depending on your genetics and your tumor's characteristics. This screening study simply collects samples from you to run tests that will tell us if you're a good match for one of their treatment trials. You'll be asked to provide a cheek swab (like a Q-tip rubbed inside your mouth) and a saliva sample. These tests look at your HLA type—think of it as your immune system's genetic fingerprint. We'll also need a sample of your tumor tissue (either one you've already had removed and stored, or a fresh biopsy) to see if your cancer has the right 'markers' that the new therapy can target. No actual treatment happens in this screening study; it's just information gathering to see if you're eligible for the real treatment trial. If the tests show you're a match, you'll be invited to join one of TScan's actual treatment studies. If you're not a match, the screening results will still be valuable information for your doctors.
What This Trial Does
TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous T cells are engineered to express a T cell receptor that recognizes tumor-associated antigens presented on specific Human Leukocyte Antigen (HLA) molecules. The purpose of this screening study is to collect samples to conduct HLA genotyping, HLA Loss of Heterozygosity (LOH) assessment, and expression of Tumor-associated Antigens (TAA) testing. These results will be used to determine if participants meet the eligibility criteria for these parameters and could potentially be enrolled in a TScan clinical study.
How It Works
This multicenter screening study will be conducted to determine a participant's tumor-associated antigen expression, HLA types and loss of HLA heterozygosity status for potential enrollment in a TScan sponsored clinical study. No treatment intervention will occur as part of this screening study. Participants will be required to provide a buccal swab to assess their HLA types and a saliva sample to assess for HLA loss of heterozygosity. For participants with an HLA type for which TScan has an open clinical study, archival tissue (less than 8 months old) will be needed to assess for tumor-associated antigen expression. If archival tissue is not available or older than 8 months, a fresh tumor biopsy will be required.
Who Can Join
Inclusion Criteria
- Willing and able to provide written informed consent.
- Male or female aged ≥18 years at the time of signing the informed consent.
- Have one of the following histologically or cytologically confirmed locally advanced (unresectable) or metastatic solid tumor for which the Sponsor has an associated clinical study:
- Head and neck cancer
- Cervical cancer
- Non-small cell lung cancer
- HPV positive anogenital cancers
- Sarcoma
- Other cancers with a reasonable likelihood of expressing 1 or more antigens included in a TScan clinical trial, following approval by the TScan Medical Monitor or their delegate.
- Willing to provide a buccal swab for HLA testing
- Willing to provide a saliva sample to use as a normal control for the LOH assay
- Have access to an adequate FFPE tumor block that is \<8 months old or is willing to provide a fresh core-needle biopsy from a location deemed safe by the treating medical team.
Exclusion Criteria
- Participants undergoing anticancer therapy with curative intent such as tumor surgical resection with or without neoadjuvant/adjuvant therapy, or definitive chemoradiation, unless they have locoregionally advanced disease and are expected to have a high risk of relapse after their curative intent therapy as determined by the treating investigator.
Treatments
Tumor and HLA Profiling (DIAGNOSTIC_TEST)
HLA genotyping and tumor tissue profiling for certain tumor-associated antigens and HLA LOH.
Trial Sites (21)
HonorHealth Research and Innovation Institute
Scottsdale, Arizona, United States
University of California San Diego
San Diego, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Memorial Healthcare System
Hollywood, Florida, United States
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Orlando Health
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
University of Chicago
Chicago, Illinois, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
University of Minnesota, Masonic Cancer Center
Minneapolis, Minnesota, United States
Columbia University Herbert Irving Comprehensive Cancer Center
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
The Cleveland Clinic
Cleveland, Ohio, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, United States
Allegheny Hospitals Network
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States