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Third Party Viral Specific T-cells (VSTs)

Third Party Viral Specific T-cells (VSTs)

Recruiting
2 years and older
All
Phase 2

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Overview

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 cells.

Eligibility

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
  • 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 details
    Viral Infection
    Viral Reactivation
    Infection in an Immunocompromised Host

NCT02532452

Children's Hospital Medical Center, Cincinnati

29 January 2024

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