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RECRUITING
NCT02532452
PHASE2

Third Party Viral Specific T-cells (VSTs)

Sponsor: Children's Hospital Medical Center, Cincinnati

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Days - Any

Study Type

INTERVENTIONAL

Enrollment

750

Start Date

2015-09-02

Completion Date

2027-12

Last Updated

2025-12-16

Healthy Volunteers

No

Interventions

BIOLOGICAL

Viral 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