Actively Recruiting
Pilot Study of Haploidentical Donor Adenovirus Specific T-lymphocytes to Treat Refractory Adenovirus Infections
Led by Nationwide Children's Hospital · Updated on 2025-05-13
12
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This open-label, single-arm, phase I/II clinical trial will assess the safety and efficacy of related donor adenovirus-specific T lymphocytes isolated from whole blood or leukapheresis products. The adenovirus-specific T lymphocytes will be generated automatically by the CliniMACS Prodigy using the CliniMACS Cytokine Capture System (IFN-γ) after incubation with MACS GMP PepTivator Peptide Pools of Hexon 5 for enrichment.
CONDITIONS
Official Title
Pilot Study of Haploidentical Donor Adenovirus Specific T-lymphocytes to Treat Refractory Adenovirus Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 0 days to 60 years
- Solid organ transplant recipients (renal, heart, lung, liver, pancreas, small bowel, multi-visceral) more than 28 days post-transplant at screening
- Patients with malignancy receiving or who have received chemotherapy within 6 months
- Patients with autoimmune or autoinflammatory conditions not linked to primary immunodeficiency
- Patients receiving or who have received systemic immunosuppressive therapies within 30 days prior to screening, including biologics, calcineurin inhibitors, mTOR inhibitors, or corticosteroids
- Patients without known immunocompromised conditions
- Documented refractory adenovirus infection (DNAemia or rising viral load despite antiviral therapy >14 days)
- Evidence of refractory adenovirus end organ disease despite antiviral therapy >14 days
- Medical intolerance to antiviral therapies including renal toxicity, bone marrow suppression, gastrointestinal symptoms, or related organ injury
- High risk for antiviral failure due to recurrent adenovirus reactivations or recent increase in immunosuppressants
- Negative pregnancy test if applicable
- Provided signed informed consent or assent
You will not qualify if you...
- Received anti-thymocyte globulin, alemtuzumab, cytoxan, or other T-cell depleting drugs or monoclonal antibodies within 28 days before enrollment
- Receiving corticosteroids at doses ≥0.5 mg/kg/day or ≥20 mg/day prednisone equivalent at enrollment
- Recipients of allogeneic hematopoietic stem cell transplant
- Uncontrolled infections other than adenovirus, including bacterial infections without stable therapy or signs of progression, fungal infections without response to therapy, or progressing infections causing hemodynamic instability
- Poor performance status (Karnofsky or Lansky score ≤30%)
- Enrolled in another experimental trial for refractory adenovirus infection
- Treatment with other investigational anti-adenoviral agents during the study until Week 12
- Recent treatment with brincidofovir (CMX001) without 72-hour washout before infusion
- Known HIV infection
- Pregnant or breastfeeding females or those unwilling to use effective birth control during treatment
- Known hypersensitivity to iron dextran
- Unable or unwilling to comply with study 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: 1 location
1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
Research Team
M
Melinda Triplet
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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