CMV CTLs in Neonates With CMV Infection (NCT05564598) | Clinical Trial Compass
RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
United States23 participantsStarted 2023-07-01
Plain-language 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
Who can participate
Age range0 Days – 21 Days
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
To determine the safety of giving CMV CTLs combined with anti-viral therapy in neonates with CMV
Timeframe: 12 weeks
2
To determine response rates to treatment with CMV CTLS and anti-viral medication