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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor and HLA Profiling | Diagnostic Test | HLA genotyping and tumor tissue profiling for certain tumor-associated antigens and HLA LOH. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of subjects with TAA expression, HLA typing and HLA loss. | To identify participants that could potentially be eligible for the TScan Therapeutics clinical trials. | 3 years |
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Inclusion Criteria:
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.
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The purpose of this study is to identify participants with locally advanced (unresectable) or metastatic solid tumors that could potentially be eligible for a TScan clinical study.
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| Name | Affiliation | Role |
|---|---|---|
| Dawn Pinchasik, MD | TScan Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research and Innovation Institute | Scottsdale | Arizona | 85258 | United States | ||
| University of California San Diego |
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Diagnostic Test: Tumor Profiling for TAA expression, HLA typing and HLA loss.
| San Diego |
| California |
| 92037 |
| United States |
| Yale Cancer Center | New Haven | Connecticut | 06510 | United States |
| Memorial Healthcare System | Hollywood | Florida | 33021 | United States |
| University of Miami, Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| Orlando Health | Orlando | Florida | 32806 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| University of Minnesota, Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Columbia University Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Oncology Hematology Care | Cincinnati | Ohio | 45242 | United States |
| The Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| OU Health Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Providence Cancer Institute Franz Clinic | Portland | Oregon | 97213 | United States |
| Allegheny Hospitals Network | Pittsburgh | Pennsylvania | 15224 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D012509 | Sarcoma |
| D000098943 | Uveal Melanoma |
| D002277 | Carcinoma |
| D000230 | Adenocarcinoma |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018307 | Neoplasms, Squamous Cell |
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