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



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/18/2019
Start Date:December 2015
End Date:November 2025
Contact:Ramaswamy Govindan, MD
Email:rgovinda@DOM.wustl.edu
Phone:314-747-7405

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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 at least 18 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 NY-ESO-1 and/or LAGE-1a and MAGE A10. 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.

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.

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 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 a fresh biopsy is feasible, OR;

ii. 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.
We found this trial at
19
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Justin F Gainor, M.D.
Phone: 617-724-4000
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Adekunle O Odunsi, MD, PhD
Phone: 716-845-3089
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Principal Investigator: Taofeek K Owonikoko, MD, PhD
Phone: 404-778-4995
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Atlanta, GA
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
Principal Investigator: Nancy Hardy, MD
Phone: 410-328-1160
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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500 Upper Chesapeake Drive
Bel Air, Maryland 21014
Principal Investigator: Ashkan Bahrani, MD
Phone: 443-643-1181
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Bel Air, MD
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Boca Raton, Florida 33486
Principal Investigator: Edgardo Santos, MD
Phone: 561-955-4800
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Kai He, MD
Phone: 614-366-4139
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Duarte, California 91010
Principal Investigator: Karen Reckamp, MD
Phone: 626-256-4673
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20 Duke Medicine Circle
Durham, North Carolina 27710
Principal Investigator: Jeffrey M Clarke, MD
Phone: 919-668-1462
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Durham, NC
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: John V Heymach, MD
Phone: 713-792-6363
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Indianapolis, Indiana 46202
Principal Investigator: Shadia I Jalal, MD
Phone: 317-274-4505
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Indianapolis, IN
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1475 NW 12th Ave
Miami, Florida 33136
(305) 243-1000
Principal Investigator: Chukwuemeka Ikpeazu, MD
Phone: 305-243-0864
University of Miami, Sylvester Comprehensive Cancer Center Sylvester Comprehensive Cancer Center integrates all cancer-related activities...
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Nashville, Tennessee 37203
Principal Investigator: Melissa Johnson, MD
Phone: 615-339-4214
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Philadelphia, Pennsylvania 19111
Principal Investigator: Anthony Olszanski, MD, RPh
Phone: 215-728-4750
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Ramaswamy Govindan, MD
Phone: 314-286-2098
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Stanford, California 94305
Principal Investigator: Joel W Neal, MD, PhD
Phone: 650-723-0186
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Tampa, Florida 33612
Principal Investigator: Ben Creelan, MD, MS
Phone: 813-745-1040
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Toronto, Ontario
Principal Investigator: Marcus Butler, MD
Phone: 416-946-4501
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7601 Osler Drive
Towson, Maryland 21204
Principal Investigator: Richard Schraeder, MD
Phone: 410-337-4569
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