Actively Recruiting
Phase I Study of Rapidly Generated Virus Specific T Cells (R-MVST) for Treating Refractory Viral Infections in Immunodeficient Children and Young Adults
Led by Columbia University · Updated on 2025-07-31
18
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and feasibility of using rapidly generated virus specific T cells (R-MVST) to treat patients with viral infections caused by Epstein Barr Virus (EBV), cytomegalovirus (CMV), adenovirus (ADV), or BK virus who have weakened immune systems. These viruses often reactivate in patients whose immune function is suppressed, such as those who have received stem cell or organ transplants, or have other immune deficiencies. The study is a Phase 1, non-randomized, open-label trial focused on assessing potential toxicities like graft-versus-host disease (GVHD) and the overall response to treatment. Participants will receive infusions of R-MVST cells generated from partially human leukocyte antigen (HLA)-matched healthy donors or the original transplant donor if available. The study includes three groups: patients who received allogeneic hematopoietic stem cell transplants (Group A), solid organ transplant recipients (Group B), and other immunocompromised patients (Group C). Each group follows a dose escalation schedule with different R-MVST cell doses administered based on body weight. Throughout the study, participants will be closely monitored for safety outcomes such as toxicities and GVHD for up to 28 days after infusion. Researchers will also track viral load changes, recovery of antiviral immunity, clinical responses, overall survival up to one year post-infusion, and secondary graft failure at day 28. The total participation duration varies depending on monitoring and follow-up assessments conducted at regular intervals.
CONDITIONS
Brief 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 under 26 years
- History of hematopoietic cell transplant (HCT) or solid organ transplant (SOT) with viral reactivation or symptomatic disease from EBV, CMV, adenovirus, or BK virus
- Suboptimal response to standard antiviral therapy
- Recurrent or multiple viral infections requiring intervention
- At least one viral infection must be refractory to standard treatment
You will not qualify if you...
- Other uncontrolled infections except CMV, EBV, adenovirus, or BK virus
- Receiving corticosteroids at 0.5 mg/kg prednisone or higher
- Received anti-thymocyte globulin, alemtuzumab, or similar T-cell immunosuppressive antibodies within 28 days
- Received methotrexate or other toxic immunosuppressants within 7 days
- Received extracorporeal photopheresis within 28 days
- Received checkpoint inhibitors within 3 drug half-lives before infusion
- Donor lymphocyte infusion within 28 days
- Graft-versus-host disease grade 2 or higher
- Biopsy-proven acute rejection in solid organ transplant recipients
- Active uncontrolled malignancy relapse
- Pregnant or breastfeeding
- Unwillingness to use effective contraception if of childbearing potential
- Uncontrolled illnesses affecting study compliance
- Received investigational products within 14 days
- Unable or unwilling to receive infusions at the study hospital
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 - Up to 28 days post R-MVST infusion
Participants receive an infusion of rapidly generated virus specific T cells (R-MVST) to treat refractory viral infections related to their immunodeficient condition.
1 infusion visit and follow-up visits during the 28 days post-infusion
Duration - Up to 1 year after the initial R-MVST infusion
Participants are monitored for up to 1 year after the initial R-MVST infusion to assess long-term response, survival, and safety outcomes.
Periodic follow-up visits for up to 1 year
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
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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