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HLA TestingA Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors

Sponsor:

TScan Therapeutics, Inc.

Code:

NCT05812027

Conditions

Head and Neck Cancer

Cervical Cancer

Non Small Cell Lung Cancer

HPV16 Related Cancers

Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tumor and HLA Profiling

Study Details

Brief 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.

Conditions

Head and Neck Cancer

Cervical Cancer

Non Small Cell Lung Cancer

HPV16 Related Cancers

Sarcoma

Study ID

NCT05812027

Start date

Jun 26, 2023

Status verified date

Jun, 2025

Completion date

Jan 14, 2027

Anticipated

Primary completion date

Jan 1, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1150 participants

Anticipated

Interventions and Outcome Measures

Interventions

Tumor and HLA Profiling

HLA genotyping and tumor tissue profiling for certain tumor-associated antigens and HLA LOH.

Primary outcome measure

Frequency of subjects with TAA expression, HLA typing and HLA loss. [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Erica Gagnon

857-399-9887 medicalaffairs@tscan.com

Kapadi CRO

843-321-9429 kapadisites@kapadi.com

Locations

HonorHealth Research and Innovation Institute

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Justin Moser, MD

480-323-1364 clinicaltrials@honorhealth.com

University of California San Diego

Recruiting

San Diego, California, United States, 92037

Contacts

Jasmine Cate

858-246-3035 jcate@health.ucsd.edu

Principal Investigator:

Sandip Patel, MD

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Jialing Zhang

475-234-9684 Jialing.zhang@yale.edu

Principal Investigator:

Michael Hurwitz, MD

Memorial Healthcare System

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Brian Pico, MD

954-265-1847 bpico@mhs.net

University of Miami, Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Marialby Donis Ramos

305-243-1000 mxd4514@med.miami.edu

Principal Investigator:

Jose Lutzky, MD

Orlando Health

Recruiting

Orlando, Florida, United States, 32806

Contacts

Melinda Porter

321-841-7246 janice.porter@orlandohealth.com

Principal Investigator:

Sajeve Thomas, MD

University of South Florida

Recruiting

Tampa, Florida, United States, 33606

Contacts

Monica Rengifo Pardo

mrengiopardo@tgh.org

Principal Investigator:

Adrian Kohut, MD

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Principal Investigator:

Daniel Olson, MD

Norton Cancer Institute

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Ben Orem

502-629-2500 ben.orem@nortonhealthcare.org

Principal Investigator:

Jaspreet Grewal, MD

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Marie Ventimiglia

313-576-9271 ventimim@karmanos.org

Principal Investigator:

Ira Winer, MD

University of Minnesota, Masonic Cancer Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Manar Al-Assi

malassi@umn.edu

Principal Investigator:

Benjamin Manning, MD

Columbia University Herbert Irving Comprehensive Cancer Center

Recruiting

New York, New York, United States, 10032

Contacts

Elizabeth Shelton, MPH

cancerclinicaltrials@cumc.columbia.edu

Principal Investigator:

Brian Henick, MD

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

UNC Immunotherapy Team

919-445-4208 UNCImmunotherapy@med.unc.edu

Principal Investigator:

Jared Weiss, MD

Oncology Hematology Care

Recruiting

Cincinnati, Ohio, United States, 45242

Contacts

AskSarah AskSarah Help Line

844-482-4812

Principal Investigator:

David Waterhouse, MD

The Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Cancer Answer Line

216-444-7923

Principal Investigator:

James Isaacs, MD

OU Health Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Cynthia Lowery

Cynthia-Lowery@ouhsc.edu

Principal Investigator:

Manu Pandey, MD

Providence Cancer Institute Franz Clinic

Recruiting

Portland, Oregon, United States, 97213

Contacts

Rom Leidner, MD

503-215-2614 CanRsrchStudies@providence.org

Principal Investigator:

Rom Leidner, MD

Allegheny Hospitals Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Shelly Evans

shelly.evans@ahn.org

Principal Investigator:

Thomas Curley, MD

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Barb Stadterman

stadtermanbm@upmc.edu

Principal Investigator:

Jason Luke, MD

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

AskSarah AskSarah Help Line

844-482-4812

Principal Investigator:

Meredith Ann McKean, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Luciana Narvaez

713-798-1694 Luciana.narvaez@bcm.edu

Principal Investigator:

Meera Patel, MD

More Information

Sponsor

TScan Therapeutics, Inc.

Last update posted

Jun 26, 2025

Last verified

Jun, 2025

Keywords

Loss of Heterozygosity
HLA
Carcinoma
MAGE-A1
Adenocarcinoma
Squamous Cell Carcinoma
Epithelial Carcinoma
HPV Positive Cancers
TScan Therapeutics
TSCAN-002
TSCAN-003
PRAME
MAGE-C2
MAGE-A4
Sarcoma
Human Papillomavirus
Solid Tumor
HPV Positive Anogenital Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by TScan Therapeutics, Inc. on 2025-06-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.