ACTIVE_NOT_RECRUITING

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

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Conditions

Head and Neck CancerCervical CancerNon Small Cell Lung CancerHPV16 Related CancersSarcomaUveal MelanomaNUT CarcinomaLoss of HeterozygosityHLACarcinomaMAGE-A1AdenocarcinomaSquamous Cell CarcinomaEpithelial CarcinomaHPV Positive CancersTScan TherapeuticsTSCAN-002TSCAN-003PRAMEMAGE-C2MAGE-A4Human PapillomavirusSolid TumorHPV Positive Anogenital Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-06-26
Study Completion:2027-01-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05812027

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willing and able to provide written informed consent.
  2. * Male or female aged ≥18 years at the time of signing the informed consent.
  3. * 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:
  4. * Head and neck cancer
  5. * Cervical cancer
  6. * Non-small cell lung cancer
  7. * HPV positive anogenital cancers
  8. * Sarcoma
  9. * 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.
  10. * Willing to provide a buccal swab for HLA testing
  11. * Willing to provide a saliva sample to use as a normal control for the LOH assay
  12. * 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.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Dawn Pinchasik, MD
STUDY_DIRECTOR
TScan Therapeutics, Inc.

Study Locations (Sites)

HonorHealth Research and Innovation Institute
Scottsdale, Arizona, 85258
United States
University of California San Diego
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

Collaborators and Investigators

Sponsor: TScan Therapeutics, Inc.

  • Dawn Pinchasik, MD, STUDY_DIRECTOR, TScan Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-26
Study Completion Date2027-01-14

Study Record Updates

Study Start Date2023-06-26
Study Completion Date2027-01-14

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Head and Neck Cancer
  • Cervical Cancer
  • Non Small Cell Lung Cancer
  • HPV16 Related Cancers
  • Sarcoma
  • Uveal Melanoma
  • NUT Carcinoma