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Viral InfectionRare diseaseBiologicalPhase 2

What this study is

The purpose of this study is to demonstrate that viral specific T-cells (a type of white blood cell) can be generated from an unrelated donor and given safely to patients with viral infections.

What's being tested

  • Viral Specific VST Infusion

    Intervention · BIOLOGICAL

    VSTs will be infused into immunocompromised patients with evidence of viral infection or reactivation defined as any of the following: * Blood adenovirus PCR ≥ 1,000 * Blood CMV PCR ≥ 500 * Blood EBV PCR ≥ 9,000 * Plasma BKV PCR >1,000 * Plasma JC Virus PCR > 1,000 * Evidence of invasive adenovirus infection or disease, defined as the presence of adenoviral positivity by PCR or culture in one or more sites * Evidence of invasive CMV infection, eg pneumonitis, retinitis, colitis * Evidence of invasive EBV disease/infection, EBV-associated lymphoproliferation (EBV-LPD) defined as proven EBV-LPD by biopsy or probable EBV-LPD defined as an elevated EBV DNA level in the blood associated with clinical symptoms (adenopathy or fever or masses on imaging) but without biopsy confirmation, or EBV-associated malignancies * Evidence of symptomatic BK virus infection, which may include symptomatic hemorrhagic cystitis, or BK nephropathy * Evidence of PML or other CNS infection due to JC virus

Study details

Official title
Third Party Viral Specific T-cells (VSTs) for Treatment of Viral Infections in Immunocompromised Patients
Sponsor
Children's Hospital Medical Center, Cincinnati
Conditions
Viral Infection · Viral Reactivation · Infection in an Immunocompromised Host
Enrolling
1,000 people
Starts
2015-09-02
Est. completion
2029-12
Design
Open-label, single group, Phase 2
Record
View on ClinicalTrials.gov ↗