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NCT05183490 · ClinicalTrials.gov registry record · Phase 1
R-MVST Cells for Treatment of Viral Infections
A Phase 1 study of Cytomegalovirus Infections and BK Virus Infection, sponsored by Columbia University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT05183490: Recruiting Phase 1 study of Cytomegalovirus Infections and BK Virus Infection, sponsored by Columbia University.
NCT05183490 is a Phase 1 study of Cytomegalovirus Infections and BK Virus Infection that is actively recruiting participants, run by Columbia University. The registered enrollment target is 36 participants, below the 201-participant average among 24 other Cytomegalovirus Infections trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05183490, a Phase 1 study of Cytomegalovirus Infections and BK Virus Infection, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective is to determine the safety and feasibility of administering R-MVST cells to patients with refractory viral reactivation and/or symptomatic disease caused by Epstein Barr Virus (EBV), cytomegalovirus (CMV), adenovirus (ADV) or BK virus. R-MVST cells will be generated on-demand from the closest partially human leukocyte antigen (HLA)-matched (minimum haploidentical) healthy donors or from the original allo-transplant donor if available. The investigator will closely monitor the recipients for potential toxicities including graft-versus-host disease (GVHD) post-infusion. Secondary objectives are to determine the effect of R-MVST infusion on viral load, possible recovery of antiviral immunity post-infusion and for evidence of clinical responses and overall survival. Recipients will be monitored for secondary graft failure at day 28 post R-MVST infusion.
Primary Outcome
This is to measure the incidence of toxicity post-infusion. Toxicities to consider include: GI toxicity, renal toxicity, hemorrhagic toxicity, cardiovascular toxicity hypotension, cardiac arrhythmia and left ventricular systolic dysfunction), neurological toxicity (somnolence and seizure), coagulation toxicity, vascular toxicity and pulmonary toxicity.
Conditions Studied
Interventions
- DRUG Rapidly generated virus specific T (R-MVST) cells
Study Locations (1)
New York
- Columbia University Irving Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2022-05-03 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT05183490 shows while recruiting
NCT05183490 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 201-participant average among 24 other Cytomegalovirus Infections trials with a reported enrollment target (82% lower).
The record links to 4 conditions, with Cytomegalovirus Infections appearing as the primary indexed condition, and to 1 intervention - of which Rapidly generated virus specific T (R-MVST) cells is the first listed.
NCT05183490 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05183490 about?
NCT05183490 is a clinical study titled "R-MVST Cells for Treatment of Viral Infections". The primary objective is to determine the safety and feasibility of administering R-MVST cells to patients with refractory viral reactivation and/or symptomatic disease caused by Epstein Barr Virus (EBV), cytomegalovirus (CMV), adenovirus (ADV) or BK virus. R-MVST cells will be generated on-demand f...
What is the current status of trial NCT05183490?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2022-05-03. Estimated completion is 2026-12.
What conditions does trial NCT05183490 study?
This clinical trial studies the following conditions: Cytomegalovirus Infections, BK Virus Infection, Adenovirus, Epstein-Barr Virus Infections.
What interventions are being tested in trial NCT05183490?
The interventions under investigation include: Rapidly generated virus specific T (R-MVST) cells (DRUG).
Who is sponsoring clinical trial NCT05183490?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05183490 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cytomegalovirus Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05183490's enrollment target sits among peer trials
36 16th of 24 higher than 9 of 24 other Cytomegalovirus Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cytomegalovirus Infections 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.
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