CMV CTLs in Neonates With CMV Infection

ConditionCongenital Cytomegaloviral (CMV) Disease

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age0-21

SponsorNew York Medical College

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: ≤ 21 days of life

Birth Weight: ≥ 2500 gms

Gestational age: ≥ 34 weeks of age

Thrombocytopenia (≤ 50,000 mm3)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

CMV Cytotoxic T-Lymphocytes
Biological/Vaccine
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

Treatment groups

23 Participants

are divided into 3 treatment groups

Group A: Cohort 1 Safety Run-inExperimental treatment 2 interventions

Group B: Cohort 2 Antiviral medication + CMV CTLsExperimental treatment 2 interventions

Group C: Cohort 2 Antiviral medication onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

To determine the safety of giving CMV CTLs combined with anti-viral therapy in neonates with CMV

the incidence and severity of Grade I-IV acute GVHD within 8 weeks that is probably or directly related to CMV-CTL infusion after last CMV CTL infusion will be evaluated to determine the safety profile of CMV CTLs in neonates

Time frame

12 weeks

To determine response rates to treatment with CMV CTLS and anti-viral medication

response rates will be measured by monitoring CMV PCR levels. A complete response to CMV-CTLs will be those with undetectable viral load by qRT-PCR

Time frame

12 weeks

Sponsors and contacts

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New York Medical College

Lead sponsor

Source ClinicalTrials.gov

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