NCT03266653

EBV-specific Cytotoxic T-lymphocytes (CTLs) for Refractory EBV Infection

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: New York Medical College · Academic / Other
• Sex: All
• Age: 1 Month – 79 Years
• Healthy volunteers: Not accepted

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

Conditions

• Epstein-Barr Virus Infections
• Primary Immune Deficiency Disorder

Interventions

Type	Name	Description
DRUG	cytotoxic 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.

Timeline

• Start date: 2020-07-07
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2017-08-30
• Last updated: 2025-08-08

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study