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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: Completed Phase 1 study, sponsored by Baylor College of Medicine.
NCT00709033 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Dose-limiting toxicity is defined as development of NCI grade III - IV non-hematologic or grade IV hematologic toxicity that can be attributed to the study treatment
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 |
What the finished NCT00709033 record still lists
NCT00709033 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which autologous or syngeneic PBTLs and EBV-CTLs is the first listed.
NCT00709033 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00709033's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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