AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

CMV CTLs in Neonates With CMV Infection

RecruitingPhase 2Ages 0 Days - 21 DaysAllNew York Medical College
💬

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Age: ≤ 21 days of life * Birth Weight: ≥ 2500 gms * Gestational age: ≥ 34 weeks of age * Diagnosis of CMV viremia, viruria, and/or infection:Either one or more: Elevated CMV by RT-PCR in urine, saliva, CSF, or plasma; and/or Positive urine culture for CMV \- Moderate or Severe CMV Disease Any one or more of the following attributable to congenital CMV infection: * Thrombocytopenia (≤ 50,000 mm3) * Multiple petechiae * Hepatomegaly * Splenomegaly * Intrauterine growth retardation * Increased transaminases * Increased bilirubin * Microcephaly * Ventriculomegaly * Intracerebral calcifications * Periventricular echogenicity * Cortical or cerebral malformation * Chorioretinitis * Severe neonatal hearing loss * CMV DNA by PCR in CNS * Increased WBC for age in CNS * Minimal Organ Criteria Hematological: ANC ≥ 750/mm3, HgB ≥ 8gm/dl, Platelets ≥ 20,000/kmm3 Renal: Serum creatinine ≤ 1.0 mg/dl Hepatic: ALT/SGOT ≤3x upper normal limits * Donor Availability: Maternal donor available with a T-cell response CMV MACS® PepTivators. the donor is considered suitable if the percentage of IFN-gamma+ T cells is \> 0.01% after stimulation with PepTivators. Exclusion Criteria - * Patient receiving steroids (\> 0.5 mg/kg prednisone equivalent) on the same day of CMV CTL infusion. Antenatal steroids for lung maturation will have been cleared prior to CMV diagnosis. * Concomitant enrollment in another experimental clinical trial investigating the treatment of neonatal CMV viremia and/or infection. * Any medical condition that could compromise participation in the study according to the investigator's assessment. * Known history of HIV infection in the mother. * Patient's legally authorized representative unwilling or unable to comply with the protocol or unable to give informed consent.
💊

What it tests

  • CMV Cytotoxic T-Lymphocytes
  • Anti-viral Therapy
📍

Where

4 sites
Children's Hospital Los Angeles
Los Angeles, United States
Washington University
St Louis, United States
New York Medical College
Valhalla, United States
Nationwide Children's Hosptial
Columbus, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy