A Pilot Study in the Treatment of Refractory Epstein-Barr Virus (EBV) Infection With Related Donor EBV Cytotoxic T-Lymphocytes in Children, Adolescents and Young Adult Recipients
New York Medical College
Summary
Related donor Epstein-Barr Virus (EBV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children, adolescents and young adults with refractory EBV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant. Funding Source: FDA OOPD
Eligibility
- Age range
- 0–79 years
- Sex
- All
- Healthy volunteers
- No
1\. Patients with Epstein-Barr virus infections post allogeneic HSCT, primary immunodeficiencies or post solid organ transplant with: * Increasing or persistent quantitative EBV RT-PCR DNA copies despite two weeks of appropriate anti-viral therapy and/or * progressive clinical symptoms attributable to EBV, including biopsy proven colitis, lymphadenopathy, hepatomegaly, splenomegaly AND/OR * Medical intolerance to anti-viral therapies including: * intolerance to rituximab Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures. Perfor…
Interventions
- Drugcytotoxic t-lymphocytes
EBV specific CTLs will be generated from HLA related matched and mismatched donors in a GMP facility and administered to the patient with refractory CTLs.
Locations (8)
- Children's Hosptial Los AngelesLos Angeles, California
- University of California San FranciscoSan Francisco, California
- Johns HopkinsBaltimore, Maryland
- Washington UniversitySt Louis, Missouri
- New York Medical CollegeValhalla, New York
- Nationwide Children's HosptialColumbus, Ohio