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NCT02636855 · ClinicalTrials.gov registry record
Screening Protocol for Tumor Antigen Expression Profiling and HLA Typing for Eligibility Determination
A clinical trial, sponsored by Adaptimmune.
- Completed
- Registry status
- 9,122
- Enrollment target
NCT02636855: Completed study, sponsored by Adaptimmune.
NCT02636855 is a clinical trial that has completed, run by Adaptimmune. The registered enrollment target is 9,122 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02636855 has completed, sponsored by Adaptimmune.
- COMPLETED
- Registry status
- 9,122 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9,122 participants |
| Start Date | 2015-12 |
| Est. Completion | 2024-06-28 |
What the finished NCT02636855 record still lists
NCT02636855 is an observational study that tracks outcomes without assigning an intervention. Its 9,122 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT02636855 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02636855 about?
NCT02636855 is a clinical study titled "Screening Protocol for Tumor Antigen Expression Profiling and HLA Typing for Eligibility Determination". 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 el...
What is the current status of trial NCT02636855?
This trial is currently completed. The enrollment target is 9,122 participants. The study started on 2015-12. Estimated completion is 2024-06-28.
Who is sponsoring clinical trial NCT02636855?
This trial is sponsored by Adaptimmune, which has 13 total clinical trials registered on ClinicalTrials.gov.
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