Actively Recruiting
A Pilot Study in the Treatment of Refractory Epstein-Barr Virus Infection With Related Donor EBV Cytotoxic T-Lymphocytes in Children, Adolescents, and Young Adults
Led by New York Medical College · Updated on 2025-08-08
20
Participants Needed
8
Research Sites
52 weeks
Total Duration
On this page
Sponsors
N
New York Medical College
Lead Sponsor
C
Children's Hospital of Philadelphia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating related donor Epstein-Barr Virus (EBV) specific cytotoxic T cells (CTLs) in children, adolescents, and young adults who have refractory EBV infection after Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), have primary immunodeficiencies, or are post solid organ transplant recipients. This pilot study is sponsored by New York Medical College and funded by the FDA Office of Orphan Products Development to assess the safety and effectiveness of these CTLs in managing difficult EBV infections. Participants receive one dose of EBV-specific CTLs produced using the Miltenyi CliniMACS Prodigy Cytokine Capture System from related donors. If the patient does not respond based on EBV PCR tests, they may receive up to four additional doses, for a maximum of five doses. The CTLs are generated from HLA-related matched or mismatched donors in a specialized facility and administered under medical supervision. During the study, patients are monitored for treatment-emergent adverse events and response to treatment for 12 weeks following each infusion. Researchers will perform various assessments including EBV PCR testing to evaluate viral levels and clinical symptoms. The total participation duration depends on the number of infusions received, with close follow-up to track safety and efficacy outcomes throughout the trial period ending in December 2027.
CONDITIONS
Brief Title
EBV-specific Cytotoxic T-lymphocytes (CTLs) for Refractory EBV Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with Epstein-Barr virus infections after allogeneic HSCT, primary immunodeficiencies, or solid organ transplant with increasing or persistent EBV DNA despite two weeks of antiviral therapy or progressive EBV-related symptoms
- Patients intolerant to antiviral therapies including rituximab
- Written informed consent given by patient or legal representative before any study procedures
- Performance status greater than 30% (Lansky score for under 16 years, Karnofsky score for 16 years and older)
- Age between 0.1 and 79.99 years
- Females of childbearing potential must have negative pregnancy test
- Related donor available with T-cell response to EBV MACS PepTivator antigen(s)
- Third party related donor acceptable if original donor unavailable, with at least one HLA match and positive EBV IgG or T-cell response
- Complete donor disease screening similar to hematopoietic stem cell donors
- Informed consent obtained from donor or legal representative before collection
You will not qualify if you...
- Acute graft-versus-host disease grade higher than 2 or extensive chronic GVHD at time of CTL infusion
- Receiving steroids over 0.5 mg/kg prednisone equivalent at time of CTL infusion
- Donor lymphocyte infusion within 4 weeks before CTL infusion
- Poor performance status (Karnofsky or Lansky score 30% or less)
- Enrolled in another experimental trial for refractory EBV infection
- Any medical condition that could compromise study participation per investigator
- Known HIV infection
- Female who is pregnant, breastfeeding, or unwilling to use effective birth control during treatment
- Known hypersensitivity to iron dextran
- Unable or unwilling to comply with the protocol or give informed consent
- Known human anti-mouse antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks after each infusion
Participants receive one dose of EBV-specific cytotoxic T-lymphocytes (CTLs). If there is no response based on EBV PCRs, participants may receive up to four additional doses (up to 5 doses total).
Up to 5 infusions with follow-up visits for 12 weeks after each infusion
Trial Site Locations
Total: 8 locations
1
Children's Hosptial Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
3
Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
4
Washington University
St Louis, Missouri, United States, 63130
Actively Recruiting
5
New York Medical College
Valhalla, New York, United States, 10595
Actively Recruiting
6
Nationwide Children's Hosptial
Columbus, Ohio, United States, 43205
Actively Recruiting
7
Children's Hospital of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
8
Medical College of Wisconsin/Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Mitchell Cairo, MD
L
Lauren Harrison
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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