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NCT02510404 · ClinicalTrials.gov registry record · Phase 1
Multivirus-specific Cytotoxic T Lymphocytes (mCTL)
A Phase 1 study of Refractory Viral Infections, sponsored by Catherine Bollard.
- Completed
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
- 1
- Study location
NCT02510404 is a Phase 1 study of Refractory Viral Infections that has completed, run by Catherine Bollard. The registered enrollment target is 1 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02510404, a Phase 1 study of Refractory Viral Infections, has completed, sponsored by Catherine Bollard.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
- 1
- Study location
Study Summary
PIDD represent an expanding group of genetic disorders that compromise immunity against bacteria, viruses, and fungi. The most severe forms of PIDD cause profound susceptibility to opportunistic infections due to impaired or absent T-cell immunity. These diseases can be rapidly fatal unless treated via hematopoietic stem cell transplantation (HSCT). Chronic viral illnesses are a common presenting feature of many of these disorders, and studies have shown that survival of HSCT is profoundly impacted by the patient's pre-transplant disease status. Primary infections with viruses such as cytomegalovirus (CMV) and Epstein-Barr virus (EBV) are common, and respiratory viruses such as adenovirus also frequently cause infection. In patients with severe combined immunodeficiency (SCID), a prior study identified these viruses as the most common causes of mortality in the immediate period following HSCT. Though some forms of PIDD are amenable to HSCT without requiring conditioning chemotherapy, many forms require a variable degree of pre-conditioning to ensure that stable engraftment of the donor cells is achieved. The administration of cytotoxic chemotherapy used in the conditioning regimens can however increase the risk for regimen related toxicity and for some patients (especially those with active viral infections) this risk is particularly high, leading to high treatment related mortality rates. For these reasons, many such patients are not even considered candidates for HSCT or are delayed getting to HSCT and ultimately succumb to infection before they can receive the transplant. The primary objective of this study is to determine the safety of administering third-party multivirus-specific cytotoxic T lymphocytes (mCTL) from adult CMV seropositive donors to treat refractory viral infections in patients with primary immunodeficiency disorders (PIDD) prior to hematopoietic stem cell transplantation (HSCT).
Conditions Studied
Interventions
- BIOLOGICAL mCTLs
Study Locations (1)
District of Columbia
- Childrens National Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2014-04 |
| Est. Completion | 2019-06-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02510404
The ClinicalTrials.gov registry entry for NCT02510404 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 1 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 1 condition, with Refractory Viral Infections appearing as the primary indexed condition, and to 1 intervention - of which mCTLs is the first listed.
NCT02510404 reports 1 study location spanning 1 distinct geographic area - top geographies include District of Columbia.
Frequently Asked Questions
What is clinical trial NCT02510404 about?
NCT02510404 is a clinical study titled "Multivirus-specific Cytotoxic T Lymphocytes (mCTL)". PIDD represent an expanding group of genetic disorders that compromise immunity against bacteria, viruses, and fungi. The most severe forms of PIDD cause profound susceptibility to opportunistic infections due to impaired or absent T-cell immunity. These diseases can be rapidly fatal unless treated ...
What is the current status of trial NCT02510404?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2014-04. Estimated completion is 2019-06-08.
What conditions does trial NCT02510404 study?
This clinical trial studies the following conditions: Refractory Viral Infections.
What interventions are being tested in trial NCT02510404?
The interventions under investigation include: mCTLs (BIOLOGICAL).
Who is sponsoring clinical trial NCT02510404?
This trial is sponsored by Catherine Bollard, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02510404 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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