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NCT03180216 · ClinicalTrials.gov registry record · Phase 1
T-Lymphocytes for Prevention or Treatment of Viral Infections Following Hematopoietic Stem Cell Transplantation
A Phase 1 study of Viral Infections and Bone Marrow Transplant Infection, sponsored by Children's National Research Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT03180216 is a Phase 1 study of Viral Infections and Bone Marrow Transplant Infection that is active but no longer recruiting, run by Children's National Research Institute. The registered enrollment target is 32 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03180216, a Phase 1 study of Viral Infections and Bone Marrow Transplant Infection, is active but no longer recruiting, sponsored by Children's National Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
This Phase I dose-escalation trial is designed to evaluate the safety of rapidly generated multivirus-specific T-cell products with antiviral activity against CMV, EBV, adenovirus, HHV6, BK virus, JC virus, and human parainfluenza-3 (HPIV3), derived from eligible HSCT donors. In this trial, we will utilize a rapid generation protocol for broad spectrum multivirus-specific T cells for infusion to recipients of allogeneic hematopoietic stem cell transplant (HSCT), who are at risk of developing EBV, CMV, adenovirus, HHV6, BKV, JCV and/or HPIV3, or with PCR/culture confirmed active infection(s) of EBV, CMV, adenovirus, HHV6, BKV, JCV, and/or HPIV3 that has failed to resolve with at least 14 days of standard antiviral therapy (if available and tolerated). These cells will be derived from HSCT donors, and the study agent will be assessed at each dose for evidence of dose-limiting toxicities (DLT). This study will have two arms: Arm A will include patients who receive prophylactic treatment, and Arm B will include patients who receive VSTs for one or more active infections with targeted viruses. Determination of the study arm will be determined by the patient's clinical status. Study arms will each be analyzed for safety endpoints and secondary endpoints.
Conditions Studied
Interventions
- BIOLOGICAL Virus Specific T cells (VSTs)
Study Locations (1)
District of Columbia
- Childrens National Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2017-02-15 |
| Est. Completion | 2026-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03180216
The ClinicalTrials.gov registry entry for NCT03180216 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's National Research Institute, which has 92 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Viral Infections appearing as the primary indexed condition, and to 1 intervention - of which Virus Specific T cells (VSTs) is the first listed.
NCT03180216 reports 1 study location spanning 1 distinct geographic area - top geographies include District of Columbia.
Frequently Asked Questions
What is clinical trial NCT03180216 about?
NCT03180216 is a clinical study titled "T-Lymphocytes for Prevention or Treatment of Viral Infections Following Hematopoietic Stem Cell Transplantation". This Phase I dose-escalation trial is designed to evaluate the safety of rapidly generated multivirus-specific T-cell products with antiviral activity against CMV, EBV, adenovirus, HHV6, BK virus, JC virus, and human parainfluenza-3 (HPIV3), derived from eligible HSCT donors. In this trial, we will...
What is the current status of trial NCT03180216?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2017-02-15. Estimated completion is 2026-11.
What conditions does trial NCT03180216 study?
This clinical trial studies the following conditions: Viral Infections, Bone Marrow Transplant Infection.
What interventions are being tested in trial NCT03180216?
The interventions under investigation include: Virus Specific T cells (VSTs) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03180216?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03180216 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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