Clinical Trial 18431

Cancer Type: Thoracic
Interventions:

Study Type: Screening
Phase of Study: NA
Investigators:

  • Benjamin Creelan

Overview

Study Title

A Screening Protocol to Determine Tumor Antigen Expression and HLA Sub-Type for Eligibility Determination for Clinical Trials Evaluating the Safety and Efficacy of Autologous T Cells Expressing Enhanced TCRs in Subjects with Non-Small Cell Lung Cancer (NSCLC)

Summary

The purpose of this Screening Study is to perform two tests to test for proteins in potential participant's body to see if they might be able to participate in a Treatment Study. There is no treatment associated with this Screening Study. The results of this screening study will help study doctors to determine whether potential participants are eligible to move forward with screening for a changed T cell treatment in a Treatment Study.

Objective

This protocol supports enrollment to both the MAGE-A10 trial (pending SRC submission) and the NYESO1 trial (MCC 18342, SRC approved). In the future it may be expanded for additional trials planned by this sponsor.

Inclusion Criteria

  • Signed written informed consent
  • Histologically, or cytologically-confirmed diagnosis of advanced solid or hematologic malignancy or recurrent disease, as described in the respective Adaptimmune clinical treatment protocol (including, but not limited to myeloma, melanoma, NSCLC, head and neck, gastric, and bladder cancer)
  • Male or female 18 years of age or older
  • Life expectancy > 3 months
  • Ability to provide a blood sample
  • Ability to provide one of the following tumor tissue samples: a formalin-fixed, paraffin-embedded (FFPE) tumor block or tissue sections from a current lesion/the most current setting, OR; a fresh biopsy is feasible, OR; a FFPE archival primary tumor block or tissue sections

  • Exclusion Criteria

  • Any bleeding diathesis or coagulopathy, which at the discretion of the Investigator, may put the participant at risk
  • Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with participant¿s safety, obtaining informed consent or compliance to the screening study procedures