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CMV CTLs in Neonates With CMV Infection
NCT05564598 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05564598
The ClinicalTrials.gov registry entry for NCT05564598 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York Medical College, which has 50 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05564598 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, Missouri, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05564598?
The interventions under investigation include: CMV Cytotoxic T-Lymphocytes (BIOLOGICAL), Anti-viral Therapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05564598?
This trial is sponsored by New York Medical College, which has 50 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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