CMV CTLs in Neonates With CMV Infection
A legfontosabb adatok
- Hol
- Columbus, Los Angeles, St Louis és Vallhala (Egyesült Államok)Mind a 4 helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- Nationwide Children's HosptialColumbus, Egyesült ÁllamokContact: Masako Shimamura, MDRésztvevőt keres
- Children's Hospital Los AngelesLos Angeles, Egyesült ÁllamokContact: Ashley Gray, MDRésztvevőt keres
- Washington UniversitySt Louis, Egyesült ÁllamokContact: Carol Kao, MDRésztvevőt keres
- New York Medical CollegeVallhala, Egyesült ÁllamokContact: Mitchell Cairo, MDRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- New York Medical College
- Azonosító
- NCT05564598
- A regiszteradat frissítve
- 2026. október 28.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
A Phase II Open-Label Randomized Study of Anti-Viral Antibiotic Therapy With and Without Familial (Maternal) Cytomegalovirus (CMV) Cytotoxic T Lymphocytes (CTLs) in Neonates With Moderate/Severe Maternal Acquired CMV Infection
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. There is a cross-over design for patient assigned to SOC only if they have persistent disease.
Funding source: FDA OOPD
Bevonási feltételek: Age: ≤ 21 days of life; Birth Weight: ≥ 2500 gms. . For babies with intrauterine growth retardation (IUGR) (small for gestational age [SGA]) > 1500 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.
Kizáró feltételek: 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.