Summary
This screening study is intended for men and women = 18 to = 75 years of age who have
advanced solid or hematologic malignancy. The study will assess a subject's human leukocyte
antigen (HLA) subtype and tumor antigen expression profile. Based on the results, it will be
determined if a subject is eligible to be considered for Adaptimmune sponsored clinical
trials testing the safety and efficacy of genetically changed T cells targeting specific
tumor antigens. No treatment intervention will occur as part of this screening study.
Upon enrollment, subjects will be required to provide a blood sample for HLA subtype
analysis. If the results of the analysis match the HLA-A subtypes noted in the inclusion
criteria and do not express the HLA subtypes that are exclusionary for the available
interventional clinical trial(s), then the subject will be required to provide either an
archival tumor specimen or fresh tumor tissue biopsy. The tumor specimen will be screened at
a central laboratory for the expression (protein or gene) of multiple antigens which may
include, but are not limited to MAGE-A4. Based upon the results of these diagnostic analyses,
if eligible, subjects will be referred to an appropriate available interventional clinical
trial(s) at the discretion of the Investigator.
Following screening, tumor samples will be retained by Adaptimmune for the purpose of
developing and validating in vitro diagnostic (IVD) assay(s) for antigen expression profiling
which is required for regulatory approval of a new therapeutic product indication.