Third Party Viral Specific T-cells (VSTs)

Cincinnati Children's Hospital Medical Center

Status and phase: Enrolling; Phase 2

Conditions: Viral Infection; Infection in an Immunocompromised Host; Viral Reactivation

Treatments: Biological: Viral Specific VST Infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT02532452

2015-4184

Details and patient eligibility

About

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.

Full 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.

Enrollment: 750 estimated patients

Sex: All

Ages: 2+ days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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750 participants in 1 patient group

Viral Specific VST Infusion

Experimental group

Description:

3rd party VST infusion

Treatment:

Biological: Viral Specific VST Infusion