Third Party Viral Specific T-cells (VSTs)

Phase 2

Recruiting

• Conditions: Viral Infection; Infection in an Immunocompromised Host; Viral Reactivation
• Interventions: Biological: Viral Specific VST Infusion

• Registration Number: NCT02532452
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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.

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.

Study Timeline

• Study First Submitted: 2015-08-21
• Study First Submitted QC: 2015-08-21
• Study First Posted: 2015-08-25
• Study Start: 2015-09-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Viral Specific VST Infusion	Viral Specific VST Infusion	3rd party VST infusion

Primary Outcome Measures

Name	Time	Method
Successful production of viral specific T-cells	Within 30 days post culture initiation	Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.
Percentage of patients who do not have infusional toxicity	Through 30 minutes post infusion	Patients will be monitored for infusional toxicity
Incidence of GVHD associated with VST infusion	Through 30 days after infusion	Patients will be monitored for the development of VST associated GVHD

Secondary Outcome Measures

Name	Time	Method
Presence of viral-specific T-cells	At 30 days after infusion	Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay
Viral burden	At 30 days after infusion	The viral burden will be assessed using the protocol-defined efficacy assessment.

Trial Locations

Locations (4)

Akron Children's Hospital; 🇺🇸 Akron, Ohio, United States

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

The Ohio State University Wexner Medical Center - James Cancer Hospital; 🇺🇸 Columbus, Ohio, United States