RecruitingPhase 2NCT02532452

Third Party Viral Specific T-cells (VSTs)

Third Party Viral Specific T-cells (VSTs) for Treatment of Viral Infections in Immunocompromised Patients

Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

750 participants

Start Date

Sep 2, 2015

Study Type

INTERVENTIONAL

Conditions

Viral reactivation Viral Infection Infection in an Immunocompromised Host

Summary

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.

Eligibility

Min Age: 2 Days

Plain Language Summary

Simplified for easier understanding

This study provides virus-fighting T-cells (immune cells grown from a donor) to patients with weakened immune systems who have viral infections that are not responding to standard treatments. These third-party viral-specific T-cells (VSTs) are designed to fight viruses like CMV, EBV, or adenovirus. You may be eligible if: - You have a weakened immune system with evidence of a viral infection or reactivation - You are more than 1 day old (patients of all ages can qualify) - If you had a stem cell transplant, it was at least 21 days ago - Your steroid dose is being reduced to a low level - You can receive treatment at the Cincinnati site You may NOT be eligible if: - You have active severe graft-versus-host disease (GVHD grades II–IV) - You have an uncontrolled bacterial or fungal infection - You have uncontrolled relapse of a cancer requiring active chemotherapy - You received certain immunosuppressive antibodies (ATG or alemtuzumab) within the past 2 weeks - You have confirmed or suspected acute rejection of a solid organ transplant in the last 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALViral Specific VST Infusion

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