← Back to Search

Antiviral

CMV-Specific Immunotherapy for Congenital Cytomegalovirus Disease

Phase 2

Recruiting

Led By Mitchell Cairo, MD

Research Sponsored by New York Medical College

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial is for a new treatment for CMV in newborns. It is a safety trial to see if the new treatment is safe and effective.

Who is the study for?

This trial is for newborns under 21 days old with moderate to severe CMV disease, weighing at least 2500 grams and born after at least 34 weeks of gestation. They must have a maternal donor with an immune response to CMV. Babies on high-dose steroids, in other CMV trials, or with certain medical conditions can't participate.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of adding CMV-specific T-cells (CMV CTLs) from the mother to standard antiviral therapy (valganciclovir or ganciclovir) in treating congenital CMV infection in neonates.See study design

What are the potential side effects?

Possible side effects include reactions related to infusion of T-cells and those associated with antiviral medications such as valganciclovir or ganciclovir, which may affect blood counts and kidney function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To determine response rates to treatment with CMV CTLS and anti-viral medication

Cytomegalovirus Infections

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Cohort 2 Antiviral medication + CMV CTLsExperimental Treatment2 Interventions

Patients will receive both anti-viral medication and CMV CTLs

Group II: Cohort 1 Safety Run-inExperimental Treatment2 Interventions

The first 3 patients enrolled will receive both anti-viral medication and CMV CTLs, and treatment will be staggered every 28 days from the last dose of CMV CTLs from the prior patient.

Group III: Cohort 2 Antiviral medication onlyActive Control1 Intervention

Patients will only receive anti-viral therapy

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

New York Medical CollegeLead Sponsor

69 Previous Clinical Trials

6,038 Total Patients Enrolled

Mitchell Cairo, MDPrincipal InvestigatorNew York Medical College

13 Previous Clinical Trials

313 Total Patients Enrolled

Media Library

Anti-viral Therapy (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT05564598 — Phase 2

Congenital Cytomegalovirus Disease Research Study Groups: Cohort 1 Safety Run-in, Cohort 2 Antiviral medication + CMV CTLs, Cohort 2 Antiviral medication only

Congenital Cytomegalovirus Disease Clinical Trial 2023: Anti-viral Therapy Highlights & Side Effects. Trial Name: NCT05564598 — Phase 2

Anti-viral Therapy (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05564598 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial extend to individuals over 40 years of age?

"Individuals aged 0 Days to 21 Days are encouraged to apply for this medical trial."

Answered by AI

Has the FDA granted authorization for Cohort 2 Antiviral medication plus CMV CTLs?

"Data currently available indicates a level 2 safety rating for Cohort Two Antiviral medication + CMV CTLs, as this is still in the Phase 2 clinical trial stage with no efficacy data."

Answered by AI

Are investigators currently accepting volunteers for this experiment?

"Affirmative. Clinicaltrials.gov indicates that this research is currently recruiting; the posting was initially published on July 1st 2023 and has been refreshed as recently as October 24th 2022. The clinical trial needs 23 people to be enrolled from 4 different medical locations."

Answered by AI

Could I potentially participate in this clinical investigation?

"This scientific endeavour is recruiting 23 neonates who've been diagnosed with congenital cytomegaloviral (cmv) disease and are aged 21 days or younger. For consideration, applicants must adhere to the following requirements: Age ≤ 21 Days at birth; Birth Weight ≥ 2500 gms; Gestational age of 34 weeks or more when born; Elevated CMV detected by RT-PCR in urine, saliva, CSF, or plasma OR a Positive urine culture for CMV; Moderate/SevereCMV Disease diagnosis; Thrombocytopenia levels no higher than 50K mm3 ; Presence of multiple petech"

Answered by AI

What is the current patient count for this clinical experiment?

"Affirmative. According to the clinicaltrials.gov website, this medical trial has been open for recruitment since July 1st 2023 and was recently updated on October 24th 2022. A total of 23 patients are being sought from 4 different sites."

Answered by AI

What is the current scope of this trial in terms of participating medical locations?

"Participants are being sought at four distinct locations: Children's Hospital of Pennsylvania in Philadelphia, Nationwide Children's Hosptial in Columbus, New york Medical College in Valhalla, plus an additional 4 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CMV CTLs in Neonates With CMV Infection

Mitchell Cairo 2023. "CMV CTLs in Neonates With CMV Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05564598.

All > Cmv