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

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
HonorHealth Research and Innovation Institute
RECRUITING
Scottsdale
California
University of California San Diego
RECRUITING
San Diego
Connecticut
Yale Cancer Center
RECRUITING
New Haven
Florida
Memorial Healthcare System
RECRUITING
Hollywood
University of Miami, Sylvester Comprehensive Cancer Center
RECRUITING
Miami
Orlando Health
RECRUITING
Orlando
University of South Florida
RECRUITING
Tampa
Illinois
University of Chicago
RECRUITING
Chicago
Kentucky
Norton Cancer Institute
RECRUITING
Louisville
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
Minnesota
University of Minnesota, Masonic Cancer Center
RECRUITING
Minneapolis
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
New York
Columbia University Herbert Irving Comprehensive Cancer Center
RECRUITING
New York
Ohio
Oncology Hematology Care
RECRUITING
Cincinnati
The Cleveland Clinic
RECRUITING
Cleveland
Oklahoma
OU Health Stephenson Cancer Center
RECRUITING
Oklahoma City
Oregon
Providence Cancer Institute Franz Clinic
RECRUITING
Portland
Pennsylvania
Allegheny Hospitals Network
RECRUITING
Pittsburgh
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Tennessee
Sarah Cannon Research Institute
RECRUITING
Nashville
Texas
Baylor College of Medicine
RECRUITING
Houston
Contact Information
Primary
Erica Gagnon
medicalaffairs@tscan.com
857-399-9887
Backup
Kapadi CRO
kapadisites@kapadi.com
843-321-9429
Time Frame
Start Date: 2023-06-26
Estimated Completion Date: 2027-01-14
Participants
Target number of participants: 1150
Sponsors
Leads: TScan Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

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