Virus-specific T cells for adenovirus infection after stem cell transplantation are highly effective and class II HLA restricted.
Jeremy D Rubinstein, Xiang Zhu, Thomas Leemhuis...
https://pubmed.ncbi.nlm.nih.gov/34473237/Actively Recruiting
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-12-16
750
Participants Needed
3
Research Sites
N/A
Total Duration
This research investigates the use of donor-derived viral specific T-cells VSTs to treat viral infections occurring after allogeneic stem cell transplant. Viral infections such as cytomegalovirus, Epstein-Barr virus, adenovirus, BK virus, and JC virus are common complications following transplant and can cause serious health issues. The study aims to find an easier and potentially safer way to manage these infections, which currently require prolonged and sometimes toxic antiviral treatments. The donor who matches the stem cell transplant recipient will provide a blood sample to create the VSTs in the lab. These cells are grown and stored in a freezer until needed. If the patient shows signs of viral infection after transplant, they may receive up to five infusions of these virus-fighting cells spaced 14 to 21 days apart. The cells are given to help the patients immune system fight the virus, and more infusions may be given based on the patients response. During the study, patients will be closely monitored with physical exams and blood tests both in the hospital and outpatient settings. Blood and urine samples will be collected before each infusion and regularly for up to a year after the final infusion. Researchers will assess how well the VSTs are produced, any infusion-related side effects, and the presence of viral infections. The goal is to evaluate the safety and viral response to this treatment over time.
CONDITIONS
Donor-Derived Viral Specific T-cells (VSTs)
J
Jamie Wilhelm, BS
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Children's Hospital Medical Center, Cincinnati
Lead Sponsor
Hoxworth Blood Center
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Donor‑derived VST infusion | Standard antiviral management |
|---|---|---|
| What it is | An investigational infusion of donor‑derived virus‑specific T cells given to transplant recipients with virus reactivation. | Current practice uses antiviral prophylaxis and preemptive antiviral drug treatment when reactivation is detected. |
| Role in trial | Investigational treatment being administered to all participants. | Not part of this trial arm; represents how similar patients are typically managed outside the study. |
| Primary use | To treat viral infection or reactivation in transplant recipients by restoring virus‑specific immunity. | To prevent or treat viral reactivation using antiviral drugs based on PCR monitoring or prophylaxis. |
| How it is given or performed | Infused virus‑specific T cells derived from the stem cell donor. | Antiviral drugs given orally or intravenously when reactivation is detected or used as prophylaxis. |
| Evidence status | Early‑phase study; efficacy and safety under evaluation in transplant recipients. | Well‑established approach with extensive evidence supporting its use for preventing or treating CMV and other viral reactivations. |
| Important risks | Potential for graft‑versus‑host disease or infusion‑related reactions. | Risks include drug‑related toxicities such as bone marrow suppression or renal toxicity depending on the antiviral agent. |
| Important limitations | Early‑phase data; manufacturing and availability of donor‑derived VSTs may limit widespread use. | Antiviral drugs can be ineffective in resistant or refractory infections and are associated with organ toxicities. |
| Patient impact | Early data suggest improved viral control, but patient‑impact outcomes are still investigational. | Reduces viral reactivation and end‑organ disease and helps improve transplant outcomes when effective and tolerated. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants must be at least 21 days post stem cell transplant and meet clinical criteria before enrollment.
Duration - Up to 5 infusions with 14 to 21 days between each
Participants receive viral specific T-cell infusions if they have evidence of viral infection after their transplant. They may receive up to 5 infusions spaced 14 to 21 days apart depending on viral response.
1 infusion visit plus blood and urine collection before each infusion
Duration - Weekly for 4 weeks, then monthly for up to 1 year after last infusion
Participants are monitored after their last infusion with physical exams and blood tests to assess viral response and safety.
Weekly visits for 4 weeks then monthly visits for up to 1 year
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Jeremy D Rubinstein, Xiang Zhu, Thomas Leemhuis...
https://pubmed.ncbi.nlm.nih.gov/34473237/Thomas J Galletta, Adam Lane, Carolyn Lutzko...
https://pubmed.ncbi.nlm.nih.gov/36736781/Children's Hospital Medical Center, Cincinnati
Lead Sponsor
Hoxworth Blood Center
Collaborating Sponsor