A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With M… (NCT05812027) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors
United States1,150 participantsStarted 2023-06-26
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of subjects with TAA expression, HLA typing and HLA loss.