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NCT01626495 · ClinicalTrials.gov registry record · Phase 1
Phase I/IIA Study of CART19 Cells for Patients With Chemotherapy Resistant or Refractory CD19+ Leukemia and Lymphoma
A Phase 1 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 1
- Development phase
- 73
- Enrollment target
NCT01626495: Completed Phase 1 study, sponsored by University of Pennsylvania.
NCT01626495 is a Phase 1 study that has completed, run by University of Pennsylvania. The registered enrollment target is 73 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01626495, a Phase 1 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 73 participants
- Enrollment target
Study Summary
This is a study for children who have been previously treated for Leukemia/Lymphoma. In particular, it is a study for people who have a type of Leukemia/Lymphoma that involves B cells (a type of white cell), which contain the cancer. This is a new approach for treatment of Leukemia/Lymphoma that involves B cells (tumor cells). This study will take the subject's white blood cells (T cells) and modify them in order to target the cancer. The subject's T cells will be modified in one or two different ways that will allow the cells to identify and kill the tumor cells (B cells). Both ways of modifying the cells tells the T cells to go to the B cells (tumor cells) and turn "on" and potentially kill the B cells (tumor cells). The modification is a genetic change to the T cells, or gene transfer, in order to allow the modified T cells to recognize your tumor cells but not other normal cells in the subject's body. These modified cells are called chimeric antigen receptor 19 (CART19) T-cells.
Interventions
- BIOLOGICAL CART-19
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2011-08-17 |
| Est. Completion | 2019-07-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01626495
The ClinicalTrials.gov registry entry for NCT01626495 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CART-19 is the first listed.
NCT01626495 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01626495 about?
NCT01626495 is a clinical study titled "Phase I/IIA Study of CART19 Cells for Patients With Chemotherapy Resistant or Refractory CD19+ Leukemia and Lymphoma". This is a study for children who have been previously treated for Leukemia/Lymphoma. In particular, it is a study for people who have a type of Leukemia/Lymphoma that involves B cells (a type of white cell), which contain the cancer. This is a new approach for treatment of Leukemia/Lymphoma that inv...
What is the current status of trial NCT01626495?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2011-08-17. Estimated completion is 2019-07-11.
What interventions are being tested in trial NCT01626495?
The interventions under investigation include: CART-19 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01626495?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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