Third Party Viral Specific T-cells (VSTs) for Treatment of Viral Infections in Immunocompromised Patients
Overview
- Phase
- Phase 2
- Intervention
- Viral Specific VST Infusion
- Conditions
- Viral Infection
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Enrollment
- 750
- Locations
- 4
- Primary Endpoint
- Successful production of viral specific T-cells
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Viral Specific VST Infusion
3rd party VST infusion
Intervention: Viral Specific VST Infusion
Outcomes
Primary Outcomes
Successful production of viral specific T-cells
Time Frame: 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
Time Frame: Through 30 minutes post infusion
Patients will be monitored for infusional toxicity
Incidence of GVHD associated with VST infusion
Time Frame: Through 30 days after infusion
Patients will be monitored for the development of VST associated GVHD
Secondary Outcomes
- Presence of viral-specific T-cells(At 30 days after infusion)
- Viral burden(At 30 days after infusion)