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)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

Kavitha Ramchandran
Kavitha Ramchandran

Clinical Professor, Medicine - Oncology

Millie Das
Millie Das

Clinical Professor, 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

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