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NCT00058786 · ClinicalTrials.gov registry record · Phase 1
Treatment of Chronic Lymphocytic B-Leukemia With IL-2 and CD-40 Autologous Tumor Cells
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00058786: Completed Phase 1 study, sponsored by Baylor College of Medicine.
NCT00058786 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00058786, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This is a research study to determine the safety and dosage of special cells that may make the patients own immune system fight the cancer. To do this, we will put a special gene into cancer cells that have been taken from the patient. This will be done in the laboratory. This gene will make the cells produce interleukin 2 (IL-2), which is a natural substance that may help the immune system kill cancer cells. Additionally, we will stimulate the cancer cells with another natural protein called CD40 ligand (CD40L), which preclinical human and animal studies suggest will help IL-2 perform better. Some of these cells will then be put back into the body. The cells are grown with normal embryonic fibroblasts. Studies of cancers in animals and in cancer cells that are grown in laboratories suggest that combining substances like IL-2 and CD40L helps the body kill cancer cells. The purpose of this study is to learn the side effects and the safest effective dose of these special cells on the disease
Interventions
- BIOLOGICAL Injection of IL-2-secreting CD40L-expressing autologous B-CLL cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2002-12 |
| Est. Completion | 2010-03 |
| Phase | Phase 1 |
What the finished NCT00058786 record still lists
NCT00058786 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Injection of IL-2-secreting CD40L-expressing autologous B-CLL cells is the first listed.
NCT00058786 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00058786 about?
NCT00058786 is a clinical study titled "Treatment of Chronic Lymphocytic B-Leukemia With IL-2 and CD-40 Autologous Tumor Cells". This is a research study to determine the safety and dosage of special cells that may make the patients own immune system fight the cancer. To do this, we will put a special gene into cancer cells that have been taken from the patient. This will be done in the laboratory. This gene will make the cel...
What is the current status of trial NCT00058786?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2002-12. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00058786?
The interventions under investigation include: Injection of IL-2-secreting CD40L-expressing autologous B-CLL cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT00058786?
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 NCT00058786's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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