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CMV-specific Cytotoxic T Lymphocytes Expressing CAR Targeting HER2 in Patients With GBM
NCT01109095 · View on ClinicalTrials.gov ↗
Study Summary
This study is for patients that have a type of brain cancer called glioblastoma multiforme (GBM). The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients. The antibody used in this study is called anti-HER2 (Human Epidermal Growth Factor Receptor 2). This antibody sticks to GBM cells because of a substance on the outside of these cells called HER2. Up to 80% of GBMs are positive for HER2. HER2 antibodies have been used to treat people with HER2-positive cancers. For this study, the HER2 antibody has been changed so that instead of floating free in the blood it is now attached to T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These chimeric receptor-T cells seem to be able to kill tumors like GBM, but they don't last very long and so their chances of fighting the cancer are limited. Therefore, developing ways to prolong the life of these T cells should help them fight cancer. We found that T cells work better if we also attach a protein called CD28 to the HER2 chimeric receptor (HER2-CAR). In this study we placed this HER2-CAR into T cells that were pre-selected for their ability to recognize Cytomegalovirus (CMV). This virus exists in most people. These CMV-specific cytotoxic T cells (CMV-T cells) will be more active since they will react to the virus as well as to tumor cells. These HER2-CD28 CMV-T cells are an investigational product not approved by the Food an
Conditions Studied
Interventions
- BIOLOGICAL HER.CAR CMV-specific CTLs
Study Locations (2)
Texas
- Houston Methodist Hospital — Houston
- Texas Children's Hospital — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2010-10 |
| Est. Completion | 2018-03-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01109095
The ClinicalTrials.gov registry entry for NCT01109095 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 678 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Glioblastoma Multiforme (GBM) appearing as the primary indexed condition, and to 1 intervention — of which HER.CAR CMV-specific CTLs is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01109095 reports 2 study locations spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01109095 about?
NCT01109095 is a clinical study titled "CMV-specific Cytotoxic T Lymphocytes Expressing CAR Targeting HER2 in Patients With GBM". This study is for patients that have a type of brain cancer called glioblastoma multiforme (GBM). The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cel...
What is the current status of trial NCT01109095?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2010-10. Estimated completion is 2018-03-07.
What conditions does trial NCT01109095 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme (GBM). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01109095?
The interventions under investigation include: HER.CAR CMV-specific CTLs (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01109095?
This trial is sponsored by Baylor College of Medicine, which has 678 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01109095 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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