©2022 Stanford Medicine
Screening Protocol for Tumor Antigen Expression Profiling and HLA Typing for Eligibility Determination
Not Recruiting
Trial ID: NCT02636855,,
Purpose
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.
Official Title
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
Stanford Investigator(s)
Kavitha Ramchandran
Clinical Professor, Medicine - Oncology
Millie Das
Clinical Associate Professor, Medicine - Oncology
Heather Wakelee
Professor of Medicine (Oncology)
Joel Neal, MD, PhD
Associate Professor of Medicine (Oncology)
Eligibility
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.
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061