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CMV CTLs in Neonates With CMV Infection

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Site details revised at 1 of 4 sitesv11
  2. Site details revised at 2 of 4 sitesv10
  3. Site details revised at 2 of 4 sitesv9
  4. Study sites: 3 to 4v8
  5. Re-verified, no change to tracked fieldsv7
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  1. Study sites: 4 to 3v6
  2. 2 versions Re-verified since May 10, 2023, no change to tracked fieldsv4-v5
  3. Phase: Phase 1/2 to Phase 2v3 Show 6 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Oct 31, 2025 to Oct 31, 2027
    • Start date: Oct 1, 2022 to Jul 1, 2023
    • Study sites: 1 to 4
    • Study completion date: Oct 31, 2026 to Oct 31, 2028
    • Interventions: Anti-viral Therapy (Drug), CMV Cytotoxic T-Lymphocytes (Drug) to Anti-viral Therapy (Drug), CMV Cytotoxic T-Lymphocytes (Biological)
  4. Eligibility criteria shortened, about 15 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05564598
Lead Sponsor New York Medical College
Conditions
(from sponsor)		 Congenital Cytomegaloviral (CMV) Disease
Related terms Disease
Enrollment 23 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov