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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether T-cells specifically targeting cytomegalovirus (CMV) and adenovirus (ADV), taken from donors using an automated device, can be a safe and effective treatment for patients who have these infections after a stem cell transplant. This Phase 2 trial aims to see if these virus-specific T-cells (VSTs) can reduce the viral load in patients' blood and improve infection outcomes. The study is sponsored by St. Jude Children's Research Hospital and involves patients up to 18 years old. The study includes two groups: Cohort A with donors identical to the stem cell donor, and Cohort B with different haploidentical donors. Donors are screened for the presence of virus-specific T-cells using a specialized flow cytometry test. Donor white blood cells are collected using the Spectra Optia system, and virus-specific T-cells are isolated using the Prodigy device over 24-36 hours. Participants receive a single intravenous infusion of these selected T-cells, with preparation involving the CliniMACS device. Participants will be closely monitored before and after the infusion, including blood tests to measure viral load at 4 weeks, 3 months, and 6 months post-infusion. The primary goal is to see a significant reduction in the virus in the blood at 4 weeks. Safety assessments include tracking adverse events such as infusion reactions, cytokine release syndrome, neurotoxicity, graft-versus-host disease, and other toxicities. The study lasts several months to assess both the effectiveness and safety of this treatment approach.
CONDITIONS
Brief 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 donor hematopoietic cell transplant and have CMV and/or ADV detected by PCR in blood that does not respond to antiviral therapy
- Persistent CMV or ADV viremia after at least 14 days of treatment or increasing viral copies after 7 days
- 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
- Heart function with shortening fraction >26% or ejection fraction >40%
- Bilirubin ≤2.5 mg/dL and ALT ≤5 times upper limit of normal
- Estimated glomerular filtration rate (GFR) >60 mL/min/1.73m2
- Free of severe infections that preclude therapy
- Lung function with FVC >50% predicted or oxygen saturation >92% on room air
- Gut diarrhea less than 1 liter/day (adults) or less than 20 mL/kg/day (children), or ≤4 stools per day above baseline
- Engrafted with ANC >500 cells/mm3 for 3 consecutive days
- Donors aged 18 years or older, haplotype matched family member, HIV negative
- Donor identical or different from stem cell donor depending on cohort
- Female donors of childbearing age must not be pregnant or breastfeeding
- Donors must meet eligibility per regulatory guidance or have urgent medical need declaration
- Recipient with 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
- Receiving steroids >0.5 mg/kg prednisone equivalent at time of infusion
- Donor Lymphocyte Infusion within 4 weeks before infusion
- Receipt of Thymoglobulin or Alemtuzumab within 30 days before infusion
- Other severe uncontrolled infections not controlled by antimicrobial therapy
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.
1 visit (in-person)
Duration - Single treatment day
Participants receive a single intravenous infusion of haplo-identical viral-specific T-cells prepared using the ClinMACS device.
1 treatment visit (in-person)
Duration - 6 months
Participants are monitored for safety and treatment effects including viral load reduction and adverse events after the infusion.
Multiple visits over 6 months post-infusion
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
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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