Third Party Viral Specific T-cells (VSTs)

Purpose

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.

Conditions

  • Viral Infection
  • Viral Reactivation
  • Infection in an Immunocompromised Host

Eligibility

Eligible Ages
Over 2 Days
Eligible Sex
All
Accepts 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 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Viral Specific VST Infusion 		3rd party VST infusion
  • 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

Recruiting Locations

Akron Children's Hospital
Akron, Ohio 44308
Contact:
Courtney Culbertson, CNP
330-543-3338
cculbertson@akronchildrens.org

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
Contact:
Jamie Wilhelm
513-803-1102
Jamie.Wilhelm@cchmc.org

The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus, Ohio 43210
Contact:
Nicole Szuminski, MS, RN, CCRC
nicole.szuminski@osumc.edu

More Details

Status
Recruiting
Sponsor
Children's Hospital Medical Center, Cincinnati

Study Contact

Jamie Wilhelm
(513) 803-1102
Jamie.Wilhelm@cchmc.org

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.