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T Cells Expressing a Fully-human AntiCD19 Chimeric Antigen Receptor for Treating B-cell Malignancies
NCT02659943 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02659943 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02659943?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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