Actively Recruiting
R-MVST Cells for Treatment of Viral Infections in Children and Young Adults
Led by Columbia University · Updated on 2025-07-31
18
Participants Needed
1
Research Sites
293 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective is to determine the safety and feasibility of administering R-MVST cells to patients with refractory viral reactivation and/or symptomatic disease caused by Epstein Barr Virus (EBV), cytomegalovirus (CMV), adenovirus (ADV) or BK virus. R-MVST cells will be generated on-demand from the closest partially human leukocyte antigen (HLA)-matched (minimum haploidentical) healthy donors or from the original allo-transplant donor if available. The investigator will closely monitor the recipients for potential toxicities including graft-versus-host disease (GVHD) post-infusion. Secondary objectives are to determine the effect of R-MVST infusion on viral load, possible recovery of antiviral immunity post-infusion and for evidence of clinical responses and overall survival. Recipients will be monitored for secondary graft failure at day 28 post R-MVST infusion.
CONDITIONS
Official Title
R-MVST Cells for Treatment of Viral Infections in Children and Young Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and young adults aged 3 months to less than 26 years of any ethnic group
- Patients with a history of hematopoietic cell transplant (HCT) or solid organ transplant (SOT) who have viral reactivation or infection from EBV, CMV, adenovirus, or BK virus causing end-organ or systemic disease
- Patients showing suboptimal response to standard antiviral therapies
- Patients with recurrent or multiple viral infections involving one or more of the listed viruses, with at least one infection requiring standard treatment
You will not qualify if you...
- Patients with other uncontrolled infections apart from CMV, EBV, adenovirus, or BK virus
- Patients with progressing bacterial or fungal infections despite treatment
- Patients receiving corticosteroids at doses of 0.5 mg/kg prednisone or higher
- Patients treated with anti-thymocyte globulin, Alemtuzumab, or other T-cell immunosuppressive antibodies within 28 days
- Patients treated with methotrexate or other toxic antimetabolite immunosuppressants within 7 days
- Patients who had extracorporeal photopheresis within 28 days
- Patients treated with checkpoint inhibitors within three drug half-lives before infusion
- Patients who received donor lymphocyte infusion within 28 days
- Patients with grade 2 or higher graft-versus-host disease (GVHD)
- Patients with biopsy-proven acute rejection in solid organ transplant recipients
- Patients with active, uncontrolled cancer relapse
- Pregnant or breastfeeding patients
- Patients unwilling to use effective contraception if of childbearing potential
- Patients with unstable illnesses such as heart failure, unstable angina, arrhythmias, or psychiatric/social issues limiting study compliance
- Patients who received other investigational products within 14 days before R-MVST infusion
- Patients unable or unwilling to receive infusions at the study site (Morgan Stanley Children's Hospital)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Columbia University Medical Center / New-York Presbyterian
New York, New York, United States, 10032
Actively Recruiting
Research Team
P
Prakash Satwani, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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