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 ii. a fresh biopsy is feasible, OR; iii. a FFPE archival primary tumor block or tissue sections
Treatment Sites in Georgia
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