Screening Protocol for Tumor Antigen Expression Profiling and HLA Typing for Eligibility Determination
Hematopoietic Malignancies
Solid Tumor
18 Years and older, Male and Female
ADP-0000-001 (primary)
NCI-2016-01399
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.
Objectives
This multicenter screening study will be conducted in order to determine a subject's tumor
antigen expression profile and HLA subtype, and subsequent eligibility for Adaptimmune
sponsored clinical treatment trials studying the safety and efficacy of autologous
genetically modified T-cells engineered with enhanced TCRs targeting specific antigens. No
treatment intervention will occur as part of this screening study. Specific Adaptimmune
sponsored interventional protocols have been designated to utilize this screening protocol to
determine preliminary eligibility. Therefore, details of the available interventional
clinical trial(s) (e.g., HLA subtype, tumor antigen, and other eligibility criteria) should
be understood before consenting subjects for this screening protocol.
For this screening study, subjects with confirmed advanced solid or hematologic malignancy or
recurrent disease, as described in the respective Adaptimmune clinical trial protocol(s),
will be required to provide a blood sample for diagnostic analysis. The blood sample will be
used for HLA subtype analysis. If the results of the analysis match the HLA subtype specified
in 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 (gene or protein) of multiple
antigens using Clinical Trial Assays. The Clinical Trial Assays to be used in this protocol
have undergone CLIA validation to establish the sensitivity, specificity and performance of
the assays. The antigens to be screened may include, but are not limited to the following:
NY-ESO-1 and/or LAGE-1a and MAGE-A10. Based upon both the tumor antigen expression and the
HLA subtype, if eligible, subjects will be referred to appropriate available interventional
trial(s) at the discretion of the Investigator.
The secondary objective of the study is the collection and analysis of tumor tissue specimens
to enable the development and validation of single and/or multiple-marker ('multiplex') IVD
assay(s) for antigen expression profiling. It is a regulatory requirement to develop the
IVD(s) as a companion diagnostic(s) to accompany a future new indication drug application(s).
Therefore all tumor specimens from this study will be retained by Adaptimmune for companion
diagnostic validation purposes.
Eligibility
- 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 to =75 years of age;
- Life expectancy > 3 months;
- Ability to provide a blood sample;
- Ability to provide one of the following tumor tissue samples: i. formalin-fixed, paraffin-embedded (FFPE) tumor block or tissue sections from a current lesion/the most current setting, OR
Treatment Sites in Georgia
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