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

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 clinical trial is studying a biological treatment called Viral Specific VST Infusion for people with infection in an immunocompromised host, viral infection, and other related conditions. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 2 Days and older.

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


Locations(4)

Akron Children's Hospital

Akron, Ohio, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

The Ohio State University Wexner Medical Center - James Cancer Hospital

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT02532452


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