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NCT02532452PHASE2Recruiting

Third Party Viral Specific T-cells (VSTs)

Children's Hospital Medical Center, Cincinnati

Start Date

9/2/2015

Completion Date

12/1/2027

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.

Detailed Description

Viral reactivation and infection is a major cause of morbidity in immunocompromised patients (including HSCT recipients). In this study we will draw blood from unrelated (third party) donors and use the blood to generate viral specific T-cells (VSTs) with specificity for Epstein-Barr virus (EBV), cytomegalovirus (CMV), adenovirus (ADV), BK virus (BKV), and JC Virus. The VSTs will be infused into immunocompromised children with specific viral infections (EBV, CMV, ADV, BKV , or JC virus). Cells will be selected for infusion based on the recipient's HLA type and the viral specificity of the cells.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: * Immunocompromised patient with evidence of viral infection or reactivation * Age \>1 day * Recipients who have had a stem cell transplant must be at least 21 days after stem cell infusion * Clinical status must allow tapering of steroids to \< 0.5mg/kg prednisone or other steroid equivalent * Must be able to receive CTL infusion in Cincinnati * Informed consent obtained by PI or sub-investigator either in person or by phone Exclusion Criteria: * Active acute GVHD grades II-IV * Uncontrolled bacterial or fungal infection * Uncontrolled relapse of malignancy requiring treatment with chemotherapy * Infusion of ATG or alemtuzumab within 2 weeks of VST infusion * Biopsy confirmed acute rejection of solid organ transplant OR empiric treatment of suspected but not confirmed acute rejection of solid organ transplant within the last 30 days

Interventions

BIOLOGICAL

Viral Specific VST Infusion

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Conditions

Viral InfectionViral ReactivationInfection in an Immunocompromised Host

Locations

Akron Children's Hospital

Akron, Ohio 44308

United States

University of Cincinnati Medical Center

Cincinnati, Ohio 45219

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States

The Ohio State University Wexner Medical Center - James Cancer Hospital

Columbus, Ohio 43210

United States