Third Party Viral Specific T-cells (VSTs) for Treatment of Viral Infections in Immunocompromised Patients
Children's Hospital Medical Center, Cincinnati
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.
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 cell…
Eligibility
- Age range
- 0+ years
- Sex
- All
- Healthy volunteers
- No
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 tr…
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 HospitalAkron, Ohio
- University of Cincinnati Medical CenterCincinnati, Ohio
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio
- The Ohio State University Wexner Medical Center - James Cancer HospitalColumbus, Ohio