Screening Protocol for Tumor Antigen Expression Profiling and HLA Typing for Eligibility Determination

Completed

Conditions studied: Solid and Hematological Malignancies

In brief

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.

Key facts

Study ID

NCT02636855

Run by

Adaptimmune

People needed

9122

Starts

2015-12-01

Expected to finish

2024-06-28

Last updated by the study team

2025-03-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• City of Hope — Duarte, California, United States
• Stanford Cancer Institute (Stanford University) — Stanford, California, United States
• Boca Raton Regional Hospital, Lynn Cancer Institute, 701 NW 13th Street — Boca Raton, Florida, United States
• University of Miami, Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Orlando Health — Orlando, Florida, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Winship Cancer Institute - Emory University — Atlanta, Georgia, United States
• Northwest Oncology and Hematology — Rolling Meadows, Illinois, United States
• Indiana University Simon Cancer Center — Indianapolis, Indiana, United States
• University of Maryland, Greenebaum Cancer Center — Baltimore, Maryland, United States
• Upper Chesapeake Medical Center, Patricia D. and M. Scot Kaufman Cancer Center — Bel Air, Maryland, United States
• UMD St. Joseph Medical Center — Towson, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke University Medical Center, Duke Cancer Institute — Durham, North Carolina, United States
• Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Tennessee Oncology- Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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