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

NCT ID: NCT02636855

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 9122 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2024-06-28

Brief 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.

Detailed Description

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.

Conditions

Solid and Hematological Malignancies

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Signed written informed consent;

2. 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);

3. Male or female ≥ 18 to ≤75 years of age;

4. Life expectancy > 3 months;

5. Ability to provide a blood sample;

6. 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

Exclusion Criteria

1. Any bleeding diathesis or coagulopathy, which at the discretion of the Investigator may put the subject at risk.

2. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adaptimmune

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

University Hospital of Navarra (Pamplona)

Pamplona, Navarre, Spain

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, , Spain

Hospital 12 De Octubre

Madrid, , Spain

Hospital Universitario 12 Octubre Avda. de Córdoba s/n

Madrid, , Spain

Centro Integral Oncológico Clara Campal, HM CIOCC (START MADRID-CIOCC)

Madrid, , Spain

Hospital Virgen del Rocio, Sevillia

Seville, , Spain

Hospital Clinico Universitario de Valencia

Valencia, , Spain

University College Hospital Macmillan Cancer Centre

London, , United Kingdom

The Christie NHS Foundation Trust

Manchester, , United Kingdom

Countries

United States; Canada; Spain; United Kingdom

Other Identifiers

ADP-0000-001

Identifier Type: -

Identifier Source: org_study_id