Actively Recruiting
EBV-specific Cytotoxic T-lymphocytes (CTLs) for Refractory EBV Infection
Led by New York Medical College · Updated on 2025-08-08
20
Participants Needed
8
Research Sites
390 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
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
Official 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 infection after allogeneic HSCT, primary immunodeficiencies, or solid organ transplant
- Persistent or increasing EBV viral DNA copies despite at least two weeks of appropriate antiviral therapy or progressive clinical symptoms due to EBV
- Medical intolerance to antiviral therapies including intolerance to rituximab
- Written informed consent provided by patient or legal representative before study procedures
- Performance status greater than 30% (Lansky score for under 16 years, Karnofsky score for over 16 years)
- Age between 0.1 and 79.99 years
- Females of childbearing potential must have a negative urine pregnancy test
- Related donor available with T-cell response to EBV PepTivator antigen(s) causing refractory infection
- If original donor unavailable or lacks T-cell response, third party related donor with at least 1 HLA match and positive EBV IgG or T-cell response
- Donor disease screening complete and informed consent obtained prior to collection
You will not qualify if you...
- Acute graft-versus-host disease greater than grade 2 or extensive chronic graft-versus-host disease at time of CTL infusion
- Receiving steroids greater than 0.5 mg/kg prednisone equivalent at time of CTL infusion
- Treated with donor lymphocyte infusion within 4 weeks prior to CTL infusion
- Poor performance status (Karnofsky or Lansky score 30% or less)
- Enrolled in another experimental clinical trial for refractory EBV infection treatment
- Any medical condition that could compromise study participation as assessed by investigator
- Known HIV infection
- Pregnant or breastfeeding female or unwilling to use effective birth control during treatment
- Known hypersensitivity to iron dextran
- Unable or unwilling to comply with 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
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
CONTACT
L
Lauren Harrison
CONTACT
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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