CMV CTLs in Neonates With CMV Infection

Launched by NEW YORK MEDICAL COLLEGE · Sep 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for newborns who have congenital Cytomegaloviral (CMV) disease, which can cause a range of health issues. The trial is looking for babies who are less than 21 days old and have moderate to severe symptoms of CMV infection. To be eligible, babies must weigh at least 2,500 grams and have specific signs of CMV disease, such as low platelet count or signs of infection in their body fluids. A maternal donor with a strong immune response to CMV is also needed to participate.

Participants in the trial will receive standard antiviral medication, either valganciclovir or ganciclovir, and may also receive special immune cells (called CMV CTLs) if the first part of the trial shows it is safe. This study is currently recruiting participants, and parents or guardians interested in enrolling their child will need to give informed consent and ensure they can follow the trial's requirements. Overall, this trial aims to find out if adding CMV CTLs to the treatment can improve outcomes for babies with this viral infection.

Gender

ALL

Eligibility criteria

• 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.