Actively Recruiting
Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection
Led by New York Medical College · Updated on 2025-08-08
20
Participants Needed
10
Research Sites
478 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 Adenovirus (ADV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered intravenously in in children, adolescents and young adults with refractory ADV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant. Funding Source: FDA OOPD
CONDITIONS
Official Title
Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with adenovirus infections after allogeneic HSCT, primary immunodeficiencies, or solid organ transplant with increasing or persistent adenovirus DNA despite two weeks of antiviral therapy and/or clinical symptoms due to adenovirus and/or intolerance to antiviral therapies including grade 2 renal insufficiency from cidofovir
- Written informed consent provided by patient or legal representative before any study procedures
- Performance status greater than 30% (Lansky for patients under 16 years, Karnofsky for patients 16 years or older)
- Age between 0.1 months and 79 years
- Females of childbearing potential must have a negative urine pregnancy test
- Related donor available with T-cell response to adenovirus viral antigens
- If original donor unavailable or lacks T-cell response, a third-party related donor with at least 1 HLA A, B, DR match and T-cell response to adenovirus antigen is allowed
- Donor disease screening completed similar to hematopoietic stem cell donors
- Donor informed consent obtained prior to collection
You will not qualify if you...
- Acute graft-versus-host disease greater than grade 2 or extensive chronic GVHD at time of CTL infusion
- Receiving steroids greater than 0.5 mg/kg prednisone equivalent at time of CTL infusion
- Received donor lymphocyte infusion within 4 weeks prior to CTL infusion
- Poor performance status (Karnofsky or Lansky score 30% or less)
- Enrolled in another experimental trial for refractory adenovirus infection
- Any medical condition that compromises 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
- Unwilling or unable to comply with protocol or provide 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: 10 locations
1
Children's Hospital 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
Children's Hospital of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
4
University of Colorado Denver
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
6
Johns Hopkins
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
7
Washington University
St Louis, Missouri, United States, 63130
Actively Recruiting
8
Nationwide Children's Hosptial
Columbus, Ohio, United States, 43205
Actively Recruiting
9
Children's Hospital of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
10
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, RN
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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