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
4
Research Sites
52 weeks
Total Duration
This research aims to demonstrate that viral specific T-cells VSTs, a type of white blood cell, can be safely produced from unrelated donors and given to immunocompromised patients with viral infections. The study focuses on patients including those who have received stem cell transplants and are experiencing viral reactivation or infection from viruses such as Epstein-Barr virus EBV, cytomegalovirus CMV, adenovirus ADV, BK virus BKV, and JC virus. These infections are a major cause of illness in immunocompromised individuals. VSTs are created by drawing blood from unrelated donors and selecting cells specific to the recipients viral infection and HLA type. The selected VSTs are then infused into the patient. This is an interventional study where the infusion is given to children and other immunocompromised patients with evidence of viral infection or reactivation. The study includes monitoring for infusion reactions and graft versus host disease GVHD. Participants will be monitored for successful production of VSTs within 30 days of culture initiation, infusion reactions within 30 minutes after the infusion, and the incidence of GVHD within 30 days post-infusion. Researchers will also assess the presence of viral-specific T-cells and viral load at 30 days after infusion. The study requires participants to be able to receive the infusion at the study location and involves informed consent procedures. The study continues through to December 2027.
CONDITIONS
Third Party Viral Specific T-cells (VSTs)
J
Jamie Wilhelm
M
Michael Grimley, MD
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Children's Hospital Medical Center, Cincinnati
Lead 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 | Third-Party VST Infusion | Current Antiviral Drug Therapy |
|---|---|---|
| What it is | A treatment that infuses third-party viral-specific T-cells (VSTs) into immunocompromised patients who have evidence of defined viral infection or reactivation. | Standard care involves antiviral drugs chosen according to the virus detected (such as ganciclovir, cidofovir, letermovir, foscarnet, or rituximab for EBV) in immunocompromised patients with viral infections or reactivation. |
| Primary use | Investigational therapy intended to treat or control viral infections or reactivation after stem cell transplant or in immunocompromised patients by restoring virus-specific immunity. | Current-care approach aims to suppress active viral replication, prevent progression, and reduce illness using antiviral medications. |
| How it is given or performed | VSTs are prepared and then infused intravenously at a medical center, into eligible immunocompromised patients following protocol-defined criteria for viral infection or reactivation. | Antiviral drugs are typically administered orally or intravenously, depending on the agent, clinical scenario, and patient needs. |
| Evidence status | Published studies demonstrate promising effectiveness and safety of VST infusion for certain viral infections in transplant recipients and immunocompromised patients, including adenovirus, BK virus, EBV, and CMV. However, broader data and ongoing evaluation are still required. | Antiviral drug therapy remains well-established and effective for controlling viral infections or reactivation in immunocompromised patients, based on guideline-supported use and extensive published experience. |
| Important limitations | Access to third-party VST infusion is limited to specialized centers with expertise in cell preparation and administration. Safety events such as GVHD and infusional toxicity are monitored, but longer-term outcomes and optimal patient selection are still being established. | Antiviral drug therapy can be limited by toxicities such as myelosuppression, renal impairment, and development of drug resistance. Some viral infections prove refractory to available agents, and prophylactic or preemptive strategies may not always prevent breakthrough. |
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.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days post infusion
Participants receive an infusion of viral specific T-cells (VSTs) targeted to their viral infection or reactivation.
1 infusion visit and follow-up assessments through 30 days
Duration - 30 days after infusion
Participants are monitored for viral-specific T-cell presence, viral burden, and possible graft versus host disease after the infusion.
Periodic visits during 30 days post infusion
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/40991376/Children's Hospital Medical Center, Cincinnati
Lead Sponsor