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NCT00889954 · ClinicalTrials.gov registry record · Phase 1
Her2 and TGFBeta Cytotoxic T Cells in Treatment of Her2 Positive Malignancy
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT00889954: Completed Phase 1 study, sponsored by Baylor College of Medicine.
NCT00889954 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00889954, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Patients have advanced stage cancer. This study is a gene transfer research study using special immune cells. 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. Investigators hope that both will work better together. Antibodies are proteins that protect the body from diseases caused from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected with germs. Both antibodies and T cells have been used to treat patients with cancers: they both have shown promise, but have not been strong enough to cure most patients. T lymphocytes can kill tumor cells but there are normally not enough of them or they are not able to kill all the tumor cells. We have done research in which we have grown "extra" T lymphocytes. We have added genes to those T lymphocytes to help them to recognize tumor cells. Although the results have been promising, we are still doing more research in this area. Antibodies usually circulate in blood and are secreted by other cells of the immune system in response to the presence of germs or abnormal cells in the body. The antibody used in this study is called anti-HER2 (Human Epidermal Growth Factor Receptor 2). This antibody sticks to HER2-positive cancer cells because of a substance on the outside of these cells called HER2.
Primary Outcome
Determine safety of one IV injection of autologous TGFBeta-resistant cytotoxic T cells (CTL) directed to Epstein Barr virus (EBV) through their native receptor and HER2 through their chimeric antigen receptor (CAR) in patients with advanced HER2- positive cancers.
Interventions
- BIOLOGICAL TGFBeta resistant HER2/EBV-CTLs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2009-05 |
| Est. Completion | 2018-01-21 |
| Phase | Phase 1 |
What the finished NCT00889954 record still lists
NCT00889954 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which TGFBeta resistant HER2/EBV-CTLs is the first listed.
NCT00889954 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00889954 about?
NCT00889954 is a clinical study titled "Her2 and TGFBeta Cytotoxic T Cells in Treatment of Her2 Positive Malignancy". Patients have advanced stage cancer. This study is a gene transfer research study using special immune cells. 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: antibodi...
What is the current status of trial NCT00889954?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2009-05. Estimated completion is 2018-01-21.
What interventions are being tested in trial NCT00889954?
The interventions under investigation include: TGFBeta resistant HER2/EBV-CTLs (BIOLOGICAL).
Who is sponsoring clinical trial NCT00889954?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00889954's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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