Actively Recruiting
Haplo-identical Viral-Specific T-cells for Treatment of Cytomegalovirus and Adenovirus Infections After Hematopoietic Cell Transplantation
Led by St. Jude Children's Research Hospital · Updated on 2026-02-23
42
Participants Needed
1
Research Sites
334 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The investigators want to learn if CMV- and ADV-specific T-cells (cells that fight infections) isolated (selected) from a donor using an automated medical device can be a safe treatment for treating patients with CMV, and ADV after transplant.This study will test the effects and safety of giving VSTs produced here at St. Jude in treating the participant's infection. Primary objective To determine the efficacy of VSTs to achieve a ≥1 log10 reduction in CMV and/or ADV viral load in the peripheral blood 4 weeks after VST infusion. When the initial viral load is \<1 log10 above the threshold of detection, the objective is to achieve a reduction to below the threshold of detection. Secondary objectives * Determine the safety of VSTs when used to treat CMV and/or ADV viremia post-HCT. * Determine the proportion of patients who achieve a negative viral load at 3 months post-infusion. * Assess the persistence of response for 6 months post-infusion.
CONDITIONS
Official Title
Haplo-identical Viral-Specific T-cells for Treatment of Cytomegalovirus and Adenovirus Infections After Hematopoietic Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who have undergone haploidentical or matched-sibling/unrelated donor hematopoietic cell transplant and have CMV or ADV detected in blood that is resistant to antiviral therapy
- Persistent or increasing CMV or ADV infection despite antiviral treatment
- No suspected or confirmed graft-versus-host disease (GVHD)
- Availability of a haploidentical donor for virus-specific T-cell isolation
- No donor lymphocyte infusion within the past 4 weeks
- Female patients of childbearing age must have a negative pregnancy test
- Ability to give informed consent or have parent/guardian consent
- Heart function with shortening fraction >26% or ejection fraction >40%
- Liver function with bilirubin ≤2.5 mg/dL and ALT ≤5 times upper limit of normal
- Kidney function with estimated glomerular filtration rate >60 mL/min/1.73m2
- Free of severe infections that prevent VST therapy
- Lung function with FVC >50% predicted or oxygen saturation >92% on room air
- Gut diarrhea less than 1 liter/day in adults or less than 20 mL/kg/day in children or no more than 4 stools per day above baseline
- Engrafted with absolute neutrophil count >500 cells/mm3 for 3 consecutive days
- Donors must be at least 18 years old and haplotype matched family members
- Donors must be HIV negative
- Female donors of childbearing age must not be pregnant or breastfeeding
- Donors meet eligibility requirements or have urgent medical need declaration
- Recipient must have CMV and/or ADV reactivation post-transplant
You will not qualify if you...
- Active graft-versus-host disease (GVHD)
- Pregnancy
- Inability to provide consent
- Need for vasopressor or ventilatory support
- Steroid treatment exceeding 0.5 mg/kg prednisone equivalent at time of VST infusion
- Donor lymphocyte infusion within 4 weeks prior to VST infusion
- Receipt of Thymoglobulin or Alemtuzumab within 30 days of VST infusion
- Other severe uncontrolled infections not controlled by antimicrobial therapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
St . Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
N
Naik Swati, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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