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NCT01945814 · ClinicalTrials.gov registry record · Phase 1
Allogeneic Multivirus - Directed Cytotoxic T Lymphocytes (CTL)
A Phase 1 study, sponsored by Catherine Bollard.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT01945814 is a Phase 1 study that has completed, run by Catherine Bollard. The registered enrollment target is 27 participants.
The verdict
NCT01945814, a Phase 1 study, has completed, sponsored by Catherine Bollard.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
In this study, investigators are trying to see if infusion of T cells (called CTLs) will prevent or treat cytomegalovirus (CMV), Epstein Barr Virus (EBV) and adenovirus (AdV) reactivation or infection. Patients with blood cell cancer, other blood disease or a genetic disease may receive a stem cell transplant. After receiving transplant, they are at risk of infections until a new immune system to fight infections grows from the cord blood cells. In this study, investigators are trying to give special cells called T cells. These cells will try to fight viruses that can cause infection. Investigators will test to see if blood cells from donor that have been grown in a special way, can prevent patients from getting an infection. EBV, AdV and CMV are viruses that can cause serious life-threatening infections in patients who have weak immune systems after transplant. T lymphocytes can kill viral cells but normally there are not enough of them to kill all the virus infected cells after transplant. Some researcher have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person during a viral infection after a bone marrow transplant. Some of these studies have shown a positive therapeutic effect in patients receiving the CTLs after a viral infection in the post-transplant period. Investigators will grow these cells from donor in the laboratory in a way that will train them to recognize and remove viruses when the T cells are given after a transplant. Since most donors have previously been infected with EBV, CMV, and adenovirus, investigators are able to use their T cells that remember these viruses to grow the CTLs. However, they now also have a new way of growing CTLs from donors who have not been infected with CMV.
Interventions
- DRUG CTL for CMV seropositive donors
- DRUG CTL for CMV naïve donors
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2014-02 |
| Est. Completion | 2018-10-16 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01945814
The ClinicalTrials.gov registry entry for NCT01945814 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. The listed sponsor is Catherine Bollard, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which CTL for CMV seropositive donors is the first listed.
NCT01945814 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01945814 about?
NCT01945814 is a clinical study titled "Allogeneic Multivirus - Directed Cytotoxic T Lymphocytes (CTL)". In this study, investigators are trying to see if infusion of T cells (called CTLs) will prevent or treat cytomegalovirus (CMV), Epstein Barr Virus (EBV) and adenovirus (AdV) reactivation or infection. Patients with blood cell cancer, other blood disease or a genetic disease may receive a stem cell...
What is the current status of trial NCT01945814?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2014-02. Estimated completion is 2018-10-16.
What interventions are being tested in trial NCT01945814?
The interventions under investigation include: CTL for CMV seropositive donors (DRUG), CTL for CMV naïve donors (DRUG).
Who is sponsoring clinical trial NCT01945814?
This trial is sponsored by Catherine Bollard, which has 14 total clinical trials registered on ClinicalTrials.gov.
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