Third Party Anti-Viral Cytotoxic T-Cells
Status: | Recruiting |
---|---|
Conditions: | Infectious Disease, Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 11/30/2018 |
Start Date: | September 2, 2015 |
End Date: | August 2022 |
Contact: | Jamie Wilhelm |
Email: | Jamie.Wilhelm@cchmc.org |
Phone: | (513) 803-1102 |
Third Party Anti-viral Cytotoxic T-cells (CTLs) for Treatment of Viral Infections in Immunocompromised Patients
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.
blood cell) can be generated from an unrelated donor and given safely to patients with viral
infections.
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 cytotoxic T-lymphocytes (CTLs) with specificity for
Epstein-Barr virus (EBV), cytomegalovirus (CMV), adenovirus (ADV), and BK virus (BKV). The
CTLs will be infused into immunocompromised children with specific viral infections (EBV,
CMV, ADV, or BKV). Cells will be selected for infusion based on the recipient's HLA type and
the viral specificity of the cells.
(including HSCT recipients). In this study we will draw blood from unrelated (third party)
donors and use the blood to generate cytotoxic T-lymphocytes (CTLs) with specificity for
Epstein-Barr virus (EBV), cytomegalovirus (CMV), adenovirus (ADV), and BK virus (BKV). The
CTLs will be infused into immunocompromised children with specific viral infections (EBV,
CMV, ADV, or BKV). Cells will be selected for infusion based on the recipient's HLA type and
the viral specificity of the cells.
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 28 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 at CCHMC
- Informed consent obtained by PI or sub-investigator at CCHMC
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 CTL infusion
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Principal Investigator: Stella Davies, MBBS, PhD
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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