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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: Active Phase 1 study of Viral Infections and Bone Marrow Transplant Infection, sponsored by Children's National Research Institute.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of patients with acute GvHD grades III-IV within 45 days of the last dose of VSTs
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 |
What the registry record for NCT03180216 still lists
NCT03180216 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03180216's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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