Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
completion around
Principal Investigator
by Sandip Patel, MD

Description

Summary

TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous participant-derived T cells are engineered to express a T cell receptor that recognizes cancer-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) 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 treatment 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

Details

This multicenter screening study will be conducted to determine a participant's tumor antigen expression profile, HLA genotype and loss of HLA for TScan sponsored clinical treatment study(s). No treatment intervention will occur as part of this screening study.

Participants will be required to provide a buccal swab to assess their HLA status. If they are positive for certain types of HLA, participants will provide saliva sample to assess HLA loss of heterozygosity. In parallel, archival tissue (less than 8 months old) will be needed to assess for tumor antigen expression. If archival tissue is older than 8 months, a fresh tumor biopsy will be required at the time of the subsequent visit.

If eligible, participants will be referred to appropriate available interventional trial(s) at the discretion of the Investigator.

Keywords

Head and Neck Cancer, Cervical Cancer, Non Small Cell Lung Cancer, Melanoma, Ovarian Cancer, HPV16 Related Cancers, Loss of Heterozygosity, HLA, TAA, MAGE-A1, Adenocarcinoma, Squamous Cell Carcinoma, Epithelial Carcinoma, HPV Positive Cancers, TScan Therapeutics, TSCAN-002, TSCAN-003, PRAME, MAGE-C2, MAGE-A4, Tumor and HLA Profiling

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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:
  • Head and neck cancer
  • Cervical cancer
  • Non-small cell lung cancer
  • Melanoma
  • Ovarian cancer
  • HPV positive anogenital cancers
  • 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 FFPE tumor block that is <8 months old or is willing to provide a fresh core-needle biopsy.

You CAN'T join if...

• 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.

Locations

  • University of California San Diego accepting new patients
    San Diego California 92037 United States
  • HonorHealth Research and Innovation Institute accepting new patients
    Scottsdale Arizona 85258 United States

Lead Scientist at UCSD

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
TScan Therapeutics, Inc.
ID
NCT05812027
Study Type
Observational
Participants
Expecting 650 study participants
Last Updated