Summary

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

Description

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.

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-associated antigen expression, HLA types and loss of HLA heterozygosity status for potential enrollment in a TScan sponsored clinical study. No treatment intervention will occur as part of this screening study.

Participants will be required to provide a buccal swab to assess their HLA types and a saliva sample to assess for HLA loss of heterozygosity. For participants with an HLA type for which TScan has an open clinical study, archival tissue (less than 8 months old) will be needed to assess for tumor-associated antigen expression. If archival tissue is not available or older than 8 months, a fresh tumor biopsy will be required.

Keywords

Head and Neck Cancer, Cervical Cancer, Non Small Cell Lung Cancer, HPV16 Related Cancers, Sarcoma, Uveal Melanoma, NUT Carcinoma, 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, Human Papillomavirus, Solid Tumor, HPV Positive Anogenital Cancer, 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 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.

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

  • Sandip Patel, MD
    Professor Of Clinical, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 73 research publications. Research interests: cancer immunotherapy · phase 1 clinical trials · cellular therapy · microbiome · thoracic oncology · NSCLC · immune related adverse events · spatial biology · cancer informatics · wearables and toxicity monitoring

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
TScan Therapeutics, Inc.
ID
NCT05812027
Study Type
Observational
Participants
Expecting 1150 study participants
Last Updated