Screening Protocol for Tumor Antigen Expression Profiling and HLA Typing for Eligibility Determination
A Screening Protocol to Determine Tumor Antigen Expression and HLA Sub-Type for Eligibility Determination for Clinical Trials Evaluating the Safety and Efficacy of Autologous T Cells Expressing Enhanced TCRs in Subjects With Solid and Hematological Malignancies
1 other identifier
observational
9,122
4 countries
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2015
Longer than P75 for all trials
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedFirst Posted
Study publicly available on registry
December 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2024
CompletedMarch 4, 2025
February 1, 2025
8.6 years
November 23, 2015
February 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of subjects with the expression (gene or protein) of multiple antigens (including, but are not limited to MAGE-A4 , and others) [ Time Frame: 10 years ]
To screen subject tumor tissue in order to determine their tumor antigen expression profile, and HLA subtype, for subsequent assessment of eligibility for various Adaptimmune sponsored targeted T cell therapy clinical trials.
10 years
Secondary Outcomes (1)
Retention of screening tumor tissue for the future development and validation of single and/or multi-plex companion diagnostic platforms for the detection of tumor antigen expression. [ Time Frame: 10 years ]
10 years
Other Outcomes (1)
Incidence of antigen expression in solid and hematological malignancies [ Time Frame: 10 years ]
10 years
Eligibility Criteria
Subjects with confirmed diagnosis of advanced solid or hematologic malignancy or recurrent disease
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Adaptimmunelead
Study Sites (36)
City of Hope
Duarte, California, 91101, United States
Stanford Cancer Institute (Stanford University)
Stanford, California, 94305, United States
Boca Raton Regional Hospital, Lynn Cancer Institute, 701 NW 13th Street
Boca Raton, Florida, 33486, United States
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Orlando Health
Orlando, Florida, 32806, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Winship Cancer Institute - Emory University
Atlanta, Georgia, 30322, United States
Northwest Oncology and Hematology
Rolling Meadows, Illinois, 60008, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46033, United States
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, 21157, United States
Upper Chesapeake Medical Center, Patricia D. and M. Scot Kaufman Cancer Center
Bel Air, Maryland, 21014, United States
UMD St. Joseph Medical Center
Towson, Maryland, 21204, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Roswell Park Cancer Institute
Buffalo, New York, 14040, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Duke University Medical Center, Duke Cancer Institute
Durham, North Carolina, 27710, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Tennessee Oncology- Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
University Hospital of Navarra (Pamplona)
Pamplona, Navarre, 31008, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital 12 De Octubre
Madrid, 28041, Spain
Hospital Universitario 12 Octubre Avda. de Córdoba s/n
Madrid, 28041, Spain
Centro Integral Oncológico Clara Campal, HM CIOCC (START MADRID-CIOCC)
Madrid, 28050, Spain
Hospital Virgen del Rocio, Sevillia
Seville, 41013, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
University College Hospital Macmillan Cancer Centre
London, WC1E 6AG, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Biospecimen
Tumor biopsy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2015
First Posted
December 22, 2015
Study Start
December 1, 2015
Primary Completion
June 28, 2024
Study Completion
June 28, 2024
Last Updated
March 4, 2025
Record last verified: 2025-02