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

August 18, 2023 updated by: Adaptimmune

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
        • Principal Investigator:
          • Marcus G Butler, MD
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitario Vall d'Hebron
        • Contact:
        • Principal Investigator:
          • Elena Garralda Cabanas
      • Barcelona, Spain, 08908
        • Not yet recruiting
        • Institut Català d'Oncologia (ICO) L´Hospitalet
        • Contact:
        • Principal Investigator:
          • Marc Oliva, MD
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital 12 de Octubre
        • Principal Investigator:
          • Jon Zugazagoitia Fraile
        • Contact:
      • Madrid, Spain, 228040
        • Recruiting
        • START Madrid-FJD, Hospital Fundacion Jimenez Diaz
        • Principal Investigator:
          • Victor Moreno, MD
        • Contact:
      • Madrid, Spain, 28040
        • Completed
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain, 28041
        • Completed
        • Hospital Universitario 12 Octubre Avda. de Córdoba s/n
      • Madrid, Spain, 28050
        • Recruiting
        • Centro Integral Oncológico Clara Campal, HM CIOCC (START MADRID-CIOCC)
        • Contact:
        • Principal Investigator:
          • Emiliano Calvo, MD
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Virgen del Rocio, Sevillia
        • Contact:
        • Principal Investigator:
          • Reyes Bernabé
      • Valencia, Spain
        • Recruiting
        • Hospital Clínico Universitario de Valencia
        • Contact:
        • Principal Investigator:
          • Andres Cervantes
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • University Hospital of Navarra (Pamplona)
        • Principal Investigator:
          • Mariano Ponz-Sarvisé, MD
        • Contact:
  • United Kingdom
      • London, United Kingdom, WC1E 6AG
        • Completed
        • University College Hospital Macmillan Cancer Centre
      • Manchester, United Kingdom, M20 4BX
        • Completed
        • The Christie NHS Foundation Trust
  • United States
    • California
      • Duarte, California, United States, 91101
        • Completed
        • City of Hope
      • Stanford, California, United States, 94305
        • Completed
        • Stanford Cancer Institute (Stanford University)
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Completed
        • Boca Raton Regional Hospital, Lynn Cancer Institute, 701 NW 13th Street
      • Miami, Florida, United States, 33136
        • Completed
        • University of Miami, Sylvester Comprehensive Cancer Center
      • Orlando, Florida, United States, 32806
      • Tampa, Florida, United States, 33612
        • Completed
        • H. Lee Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Completed
        • Winship Cancer Institute - Emory University
    • Illinois
    • Indiana
      • Indianapolis, Indiana, United States, 46033
        • Completed
        • Indiana University Simon Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21157
        • Completed
        • University of Maryland, Greenebaum Cancer Center
      • Bel Air, Maryland, United States, 21014
        • Completed
        • Upper Chesapeake Medical Center, Patricia D. and M. Scot Kaufman Cancer Center
      • Towson, Maryland, United States, 21204
        • Completed
        • UMD St. Joseph Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Completed
        • Massachusetts General Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Ramaswamy Govindan, MD
    • New York
      • Buffalo, New York, United States, 14040
        • Completed
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • David Aggen, MD
        • Contact:
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center, Duke Cancer Institute
        • Principal Investigator:
          • Jeffrey M Clarke, MD
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Completed
        • Ohio State University Wexner Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Adam Asch, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Completed
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Completed
        • Thomas Jefferson University Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology- Sarah Cannon Research Institute
        • Contact:
        • Principal Investigator:
          • Melissa Johnson, MD
      • Nashville, Tennessee, United States, 37203
        • Completed
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Principal Investigator:
          • George Blumenschein, MD
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Principal Investigator:
          • John A Charlson, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects with confirmed diagnosis of advanced solid or hematologic malignancy or recurrent disease

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 ]
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 ]
Time Frame: 10 years
Following screening for the antigen expression profile, remaining screening tissue will be used for the purpose of developing and validating companion diagnostic assays for antigen screening for regulatory approval. Tumor tissue will be used for the analytical validation (which includes testing for efficiency, sensitivity, specificity, exclusivity, accuracy and precision), as well as the clinical validation of such diagnostic assays.
10 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of antigen expression in solid and hematological malignancies [ Time Frame: 10 years ]
Time Frame: 10 years
To collect data regarding the frequency of occurrence of antigens in tumor tissue samples of different tumor types.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adaptimmune

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

November 23, 2015

First Submitted That Met QC Criteria

December 18, 2015

First Posted (Estimated)

December 22, 2015

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADP-0000-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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