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
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
Arms & 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.
Outcome measures
Primary
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Patients will be monitored for adverse events related to the infusion of EBV CTLs
Time frame: Patients will be followed for 12 weeks after each infusion
Incidence of Response to Treatment [Efficacy]
Patients will be followed for improvement in viral infection by monitoring EBV PCR weekly for response to treatment with CTLs
Time frame: Patients will be followed for 12 weeks after each infusion
Eligibility criteria
Study locations (8)
Children's Hosptial Los Angeles
Los Angeles, California, 90027
University of California San Francisco
San Francisco, California, 94158
Johns Hopkins
Baltimore, Maryland, 21287
Washington University
St Louis, Missouri, 63130
New York Medical College
Valhalla, New York, 10595
Nationwide Children's Hosptial
Columbus, Ohio, 43205
Children's Hospital of Pennsylvania
Philadelphia, Pennsylvania, 19104
Medical College of Wisconsin/Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226