Third Party Viral Specific T-cells (VSTs)

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

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.

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.

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