CMV CTLs in Neonates With CMV Infection

Conditions

• Congenital Cytomegaloviral (CMV) Disease

Eligibility Criteria

Sex

ALL

Age

0 Days - 21 Days

Healthy Volunteers

Not accepted

Interventions

• CMV Cytotoxic T-Lymphocytes — BIOLOGICAL
  Patients will receive maternal CMV CTLs on day 0. Additional doses of CMV CTLs may be re-infused at a minimum of every two weeks for a maximum of five total infusions (maximum 2.5 x 104 CD3/kg) only in patients not achieving a CR and no prior dose limiting toxicity of any prior dose.
• Anti-viral Therapy — DRUG
  All patients will receive anti-viral therapy with one of the following: 4.2.2 Valganciclovir Dosing: 16 mg/kg/dose PO q12h OR 4.2.3 Ganciclovir Dosing: 6 mg/kg/dose IV q12h Dose adjustments: * Reduce dose by 50% for ANC less than 500 cells/mm3 * Hold the dose if ≤ 200 cells/mm3 until recovery ≥ 500 cells/mm3 * Treatment will continue for 6 months

Study Details

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

Key Dates

Start date

Jul 1, 2023

Status verified

Mar 2026

Primary completion

Oct 31, 2027

Completion

Oct 31, 2028

Study Design

Enrollment

23 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1 Safety Run-in
  The first 3 patients enrolled will receive both anti-viral medication and CMV CTLs, and treatment will be staggered every 28 days from the last dose of CMV CTLs from the prior patient.
• Experimental: Cohort 2 Antiviral medication + CMV CTLs
  Patients will receive both anti-viral medication and CMV CTLs
• Active Comparator: Cohort 2 Antiviral medication only
  Patients will only receive anti-viral therapy

Primary Outcome Measure

To determine the safety of giving CMV CTLs combined with anti-viral therapy in neonates with CMV [ Time Frame: 12 weeks ]

Central Contacts

• Mitchell Cairo, MD
  914-594-2150
  [email protected]
• Edo Schaefer, MD
  [email protected]

Locations (4)

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