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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
Age: ≤ 21 days of life
Gestational age: ≥ 34 weeks of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 days old or younger.
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I am at least 34 weeks pregnant.
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I have moderate or severe CMV disease.
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I have multiple small red or purple spots on my skin.
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I have an enlarged liver.
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My spleen is enlarged.
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I have a brain malformation.
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I have an eye condition called chorioretinitis.
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I have severe hearing loss from birth.
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My white blood cell count in the brain is high for my age.
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My blood, kidney, and liver tests meet the required levels.
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I have a maternal donor with a suitable immune response for my treatment.
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I am 21 days old or younger.
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I am at least 34 weeks pregnant.
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I have moderate or severe CMV disease.
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I have health issues due to congenital CMV infection.
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I have multiple small red or purple spots on my skin.
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I have an enlarged liver.
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My spleen is enlarged.
Select...
I have a brain malformation.
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I have inflammation in the back of my eye.
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My white blood cell count in the brain is high for my age.
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My blood, kidney, and liver tests meet the required levels for the trial.
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I have a maternal donor with a suitable immune response for my treatment.

Timeline

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

New York Medical CollegeLead Sponsor
69 Previous Clinical Trials
5,988 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
~15 spots leftby Oct 2027