Outcomes with third-party virus-specific T cells after the use of single-antigen cell lines to predict HLA restriction.
Jeremy D Rubinstein, Giang Pham, Anusha Sridharan...
https://pubmed.ncbi.nlm.nih.gov/40991376Actively Recruiting
Phase 2
Age: 2Days +
All Genders
ID02532452
Third Party Viral Specific T-cells (VSTs) for Treatment of Viral Infections in Immunocompromised Patients
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-12-16
750
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 recipient’s 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
Brief Title
Third Party Viral Specific T-cells (VSTs)
Who Can Participate
Age: 2Days +
All Genders
Eligibility Criteria
You may qualify if you...
- Immunocompromised patient with evidence of viral infection or reactivation
- Age greater than 1 day
- Recipients who have had a stem cell transplant must be at least 21 days after stem cell infusion
- Clinical status must allow tapering of steroids to less than 0.5 mg/kg prednisone or other steroid equivalent
- Must be able to receive cytotoxic T-lymphocyte (CTL) infusion in Cincinnati
- Informed consent obtained by principal investigator or sub-investigator either in person or by phone
You will not qualify if you...
- Active acute graft versus host disease (GVHD) grades II-IV
- Uncontrolled bacterial or fungal infection
- Uncontrolled relapse of malignancy requiring treatment with chemotherapy
- Infusion of anti-thymocyte globulin (ATG) or alemtuzumab within 2 weeks of viral specific T-cell infusion
- Biopsy confirmed acute rejection of solid organ transplant or empiric treatment of suspected but unconfirmed acute rejection of solid organ transplant within the last 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
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
Follow-up
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
Trial Site Locations
Total: 4 locations
1
Akron Children's Hospital
Akron, Ohio, United States, 44308
Actively Recruiting
2
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Completed
3
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
4
The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus, Ohio, United States, 43210
Actively Recruiting
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Research Team
J
Jamie Wilhelm
M
Michael Grimley, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Third-Party and Patient-Specific Donor-Derived Virus-Specific T Cells Demonstrate Similar Efficacy and Safety for Management of Viral Infections after Hematopoietic Stem Cell Transplantation in Children and Young Adults.
Thomas J Galletta, Adam Lane, Carolyn Lutzko...
https://pubmed.ncbi.nlm.nih.gov/36736781Virus-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/34473237Virus-specific T-cell therapy to treat BK polyomavirus infection in bone marrow and solid organ transplant recipients.
Adam S Nelson, Daria Heyenbruch, Jeremy D Rubinstein...
https://pubmed.ncbi.nlm.nih.gov/33216887