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NCT05564598 · ClinicalTrials.gov registry record · Phase 2
CMV CTLs in Neonates With CMV Infection
A Phase 2 study of Congenital Cytomegaloviral (CMV) Disease, sponsored by New York Medical College.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
- 4
- Study locations
NCT05564598: Recruiting Phase 2 study of Congenital Cytomegaloviral (CMV) Disease, sponsored by New York Medical College.
NCT05564598 is a Phase 2 study of Congenital Cytomegaloviral (CMV) Disease that is actively recruiting participants, run by New York Medical College. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05564598, a Phase 2 study of Congenital Cytomegaloviral (CMV) Disease, is actively recruiting participants, sponsored by New York Medical College.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
- 4
- Study locations
Study Summary
Patients with moderate or severe CMV disease less than 21 days old who have a maternal donor who has a CMV response to the peptivators will be screened. All patients will receive treatment with valganciclovir or ganciclovir. There is a safety run in with treatment with CMV CTLs in cohort 1 and if found to be safe, will proceed to cohort 2 for randomization to receive antiviral therapy with or without CMV CTLs. Funding source: FDA OOPD
Primary Outcome
the incidence and severity of Grade I-IV acute GVHD within 8 weeks that is probably or directly related to CMV-CTL infusion after last CMV CTL infusion will be evaluated to determine the safety profile of CMV CTLs in neonates
Conditions Studied
Interventions
- BIOLOGICAL CMV Cytotoxic T-Lymphocytes
- DRUG Anti-viral Therapy
Study Locations (4)
California
- Children's Hospital Los Angeles - Los Angeles
Missouri
- Washington University - St Louis
New York
- New York Medical College - Vallhala
Ohio
- Nationwide Children's Hosptial - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2023-07-01 |
| Est. Completion | 2028-10-31 |
| Phase | Phase 2 |
What NCT05564598 shows while recruiting
NCT05564598 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Congenital Cytomegaloviral (CMV) Disease appearing as the primary indexed condition, and to 2 interventions - of which CMV Cytotoxic T-Lymphocytes is the first listed.
NCT05564598 reports a single indexed study location in California, Missouri, New York.
Frequently Asked Questions
What is clinical trial NCT05564598 about?
NCT05564598 is a clinical study titled "CMV CTLs in Neonates With CMV Infection". Patients with moderate or severe CMV disease less than 21 days old who have a maternal donor who has a CMV response to the peptivators will be screened. All patients will receive treatment with valganciclovir or ganciclovir. There is a safety run in with treatment with CMV CTLs in cohort 1 and if f...
What is the current status of trial NCT05564598?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2023-07-01. Estimated completion is 2028-10-31.
What conditions does trial NCT05564598 study?
This clinical trial studies the following conditions: Congenital Cytomegaloviral (CMV) Disease.
What interventions are being tested in trial NCT05564598?
The interventions under investigation include: CMV Cytotoxic T-Lymphocytes (BIOLOGICAL), Anti-viral Therapy (DRUG).
Who is sponsoring clinical trial NCT05564598?
This trial is sponsored by New York Medical College, which has 47 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05564598 being conducted?
This trial has 4 study locations across California, Missouri, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05564598's enrollment target sits among peer trials
23 1784th of 2000 higher than 212 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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