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NCT00709033 · ClinicalTrials.gov registry record · Phase 1
T-cells or EBV Specific CTLs, Advanced B-Cell NHL and CLL
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT00709033 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 3 participants.
The verdict
NCT00709033, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
Patients on this study have a type of lymph gland cancer called non-Hodgkin Lymphoma or chronic Lymphocytic Leukemia. Their lymphoma or CLL has come back or has not gone away after treatment. Because there is no standard treatment for the cancer at this time or because the currently used treatments do not work fully in all cases, patients are being asked to volunteer to take part in 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 disease: 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-CD19. This antibody sticks to lymphoma cells because of a substance on the outside of these cells called CD19. CD19 antibodies have been used to treat people with lymphoma and CLL. For this study, the anti-CD19 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, but they don't last very long and so their chances of fighting the cancer are limited. Investigators found that T cells work better if they also attach a protein called CD28 to the T cells. This protein makes the T cells more active and survive longer. Also they found that T cells that are also trained to recognize the virus that causes infectious mononucleosis (called Epstein Barr Virus or EBV) can stay in the blo
Interventions
- BIOLOGICAL autologous or syngeneic PBTLs and EBV-CTLs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2009-07 |
| Est. Completion | 2025-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00709033
The ClinicalTrials.gov registry entry for NCT00709033 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 3 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 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which autologous or syngeneic PBTLs and EBV-CTLs is the first listed.
NCT00709033 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00709033 about?
NCT00709033 is a clinical study titled "T-cells or EBV Specific CTLs, Advanced B-Cell NHL and CLL". Patients on this study have a type of lymph gland cancer called non-Hodgkin Lymphoma or chronic Lymphocytic Leukemia. Their lymphoma or CLL has come back or has not gone away after treatment. Because there is no standard treatment for the cancer at this time or because the currently used treatments ...
What is the current status of trial NCT00709033?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2009-07. Estimated completion is 2025-05.
What interventions are being tested in trial NCT00709033?
The interventions under investigation include: autologous or syngeneic PBTLs and EBV-CTLs (BIOLOGICAL).
Who is sponsoring clinical trial NCT00709033?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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