Actively Recruiting
A Pilot Study in the Treatment of Refractory Adenovirus Infection With Related Donor Adenovirus Cytotoxic T-Lymphocytes in Children, Adolescents and Young Adults
Led by New York Medical College ยท Updated on 2025-08-08
20
Participants Needed
10
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
This clinical trial focuses on children, adolescents, and young adults who have refractory adenovirus infection following allogeneic hematopoietic stem cell transplantation, primary immunodeficiencies, or solid organ transplant. The study evaluates related donor adenovirus-specific cytotoxic T cells (CTLs) produced using the Miltenyi CliniMACS Prodigy Cytokine Capture System. The goal is to assess the safety, tolerability, and response to these CTLs in treating difficult adenovirus infections. Participants will receive an intravenous infusion of adenovirus-specific cytotoxic T-lymphocytes. The dose differs based on donor match: 2.5 x 10^4 CD3/kg for matched related donors and 0.5 x 10^4 CD3/kg for mismatched related donors. If patients do not respond to the first infusion, they may receive up to five total CTL infusions. The study includes a follow-up period to monitor the effects of each infusion. During the study, participants will be closely monitored for treatment-emergent adverse events and their response to treatment over 12 weeks after each infusion. Assessments include clinical evaluations and laboratory tests to measure adenovirus levels and immune response. Safety and efficacy are the primary focus, with ongoing observation through the study period. The total duration of participation varies depending on response and number of infusions received.
CONDITIONS
Brief Title
Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients have adenovirus infection after allogeneic hematopoietic stem cell transplant, primary immunodeficiencies, or solid organ transplant
- Persistent or increasing adenovirus DNA despite two weeks of antiviral therapy or clinical symptoms related to adenovirus
- Medical intolerance to antiviral therapies such as grade 2 renal insufficiency from cidofovir
- Written informed consent provided by patient or legal representative
- Performance status above 30% (Lansky score for under 16 years, Karnofsky score for 16 years and older)
- Age between 0.1 and 79 years
- Females of childbearing potential must have a negative urine pregnancy test
- Related donor available with T-cell response to adenovirus antigen
- If original donor unavailable or lacks response, third-party related donor with at least one HLA match and T-cell response eligible
- Donor disease screening completed and informed consent obtained
You will not qualify if you...
- Acute graft-versus-host disease over grade 2 or extensive chronic graft-versus-host disease at time of CTL infusion
- Receiving steroids over 0.5 mg/kg prednisone equivalent at infusion
- Donor lymphocyte infusion within 4 weeks before CTL infusion
- Poor performance status (Karnofsky or Lansky score 30% or lower)
- Enrolled in another experimental trial for refractory adenovirus infection
- Medical conditions compromising study participation as per investigator
- Known HIV infection
- Pregnant or breastfeeding female patient or unwilling to use birth control during treatment
- Known hypersensitivity to iron dextran
- Unable or unwilling to comply with study 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.
screening and enrollment visit
Duration - Up to 12 weeks after each infusion
Participants receive adenovirus-specific cytotoxic T-lymphocytes infusions. The first infusion is given at a dose depending on donor match, and if there is no response, up to 4 additional infusions may be administered.
1 infusion with possible up to 4 additional infusions
Duration - 12 weeks after last infusion
Participants are monitored for safety and response to treatment for up to 12 weeks after the last infusion.
Visits to assess treatment-emergent adverse events and response to treatment
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
L
Lauren Harrison, RN
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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