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NCT02659943 · ClinicalTrials.gov registry record · Phase 1
T Cells Expressing a Fully-human AntiCD19 Chimeric Antigen Receptor for Treating B-cell Malignancies
A Phase 1 study of Lymphoma, B-Cell and Lymphoma, Non-Hodgkins, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT02659943 is a Phase 1 study of Lymphoma, B-Cell and Lymphoma, Non-Hodgkins that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 27 participants, below the 200-participant average among 31 other Lymphoma, B-Cell trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02659943, a Phase 1 study of Lymphoma, B-Cell and Lymphoma, Non-Hodgkins, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: The immune system fights infection and can affect cancer cells. T cells are white blood cells that are a major part of the immune system. T cells can destroy tumors. Researchers want to try to manipulate the immune system to better recognize and kill tumor cells. Objective: To test the safety of giving T cells expressing a novel fully-human anti-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) to people with advanced B-cell cancer. Eligibility: People ages 18-73 with a B-cell cancer that has not been controlled by other therapies. Design: Participants will be screened with: Physical exam Blood and urine tests Heart tests Bone marrow sample taken Scans in machines that take pictures Participants will have apheresis. Blood is removed through a needle in an arm. T cells are removed. The rest of the blood is returned through a needle in the other arm. The cells will be changed in a laboratory. Participants will get 2 chemotherapy drugs over 3 days. Two days later, participants will check into the hospital. They will get an intravenous (IV) catheter in an arm or chest vein. They will get the T cells through the IV in 1 infusion. After this, participants will stay in the hospital for at least 9 days and stay nearby for 2 weeks. Then they will have blood tests and see a doctor. Participants will have visits 6 visits for 1 year after the infusion. Some may have more follow-up visits. Participants may samples taken of spinal fluid, bone marrow, and tumors. ...
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2016-01-21 |
| Est. Completion | 2022-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02659943
The ClinicalTrials.gov registry entry for NCT02659943 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 200-participant average among 31 other Lymphoma, B-Cell trials with a reported enrollment target (86% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Lymphoma, B-Cell appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT02659943 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02659943 about?
NCT02659943 is a clinical study titled "T Cells Expressing a Fully-human AntiCD19 Chimeric Antigen Receptor for Treating B-cell Malignancies". Background: The immune system fights infection and can affect cancer cells. T cells are white blood cells that are a major part of the immune system. T cells can destroy tumors. Researchers want to try to manipulate the immune system to better recognize and kill tumor cells. Objective: To test th...
What is the current status of trial NCT02659943?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2016-01-21. Estimated completion is 2022-12-31.
What conditions does trial NCT02659943 study?
This clinical trial studies the following conditions: Lymphoma, B-Cell, Lymphoma, Non-Hodgkins.
What interventions are being tested in trial NCT02659943?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT02659943?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02659943 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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