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A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors
Trial Status: closed to accrual
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.
Inclusion Criteria
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05812027.
Locations matching your search criteria
United States
Connecticut
New Haven
Yale University
Status: Active
Name Not Available
Florida
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Temporarily closed to accrual
Name Not Available
Oklahoma
Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Name Not Available
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available
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.
