NCT06926894 R-MVST Cells for Treatment of Viral Infections in Children and Young Adults
| NCT ID | NCT06926894 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Columbia University |
| Condition | Epstein-Barr Virus |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2025-04-20 |
| Primary Completion | 2029-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2025-04-20 with a primary completion date of 2029-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Children and young adults (3 months to \<26 years) of all ethnic groups will be eligible for the treatment * Patients with history of HCT or SOT who demonstrate evidence of viral reactivation and/or infection manifesting as end-organ or systemic disease due to one or more of the following viruses: EBV, CMV, ADV or BK virus and suboptimal response to the standard of care therapy. * Recurrent or Multiple Viral Infection. RVI defined as occurrence of more than one episode of reactivation that required intervention or symptomatic disease in recipient of allogeneic HCT that required standard of care treatment. MVI defined as more than one virus reactivating (defined by PCR positivity) or causing symptomatic systemic or end-organ disease. At least one of those viral reactivations required standard of care intervention. No standard of care therapy is defined for ADV and BK. Patients with multiple infections/reactivations will be eligible as long as at least one of those viral infections meet the criterium of "refractory". Exclusion Criteria: * Patients with other uncontrolled infections, except for CMV, EBV, ADV or BK. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to the day of infusion. For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to R-MVST infusion. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. * Patients who receive corticosteroids at ≥ 0.5mg/kg prednisone or equivalent. * Patients who received anti-thymocyte globulin (ATG, Alemtuzumab (Campath), or other T-Cell immunosuppressive monoclonal antibodies in the last 28 days. * Patients who received methotrexate, or other antimetabolite-type immunosuppressants that are toxic to proliferating T cells in the last 7 days. * Patients who received extracorporeal photopheresis within the last 28 days. * Patients who received checkpoint inhibitor agents (e.g., nivolumab, pembrolizumab, ipilimumab) within 3 drug half-lives of the most recent dose to the infusion of R-MVST. * Received donor lymphocyte infusion in last 28 days. * Evidence of GVHD ≥ grade 2 * Evidence of biopsy-proven acute rejection in SOT recipients * Active and uncontrolled relapse of malignancy * Patients who are pregnant, or breastfeeding. * Female of childbearing potential, or male with a female partner of childbearing potential, unwilling to use a highly effective method of contraception. * Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Patients who have received investigational (IND) product within 14 days of infusion of the the R-MVST cells. * Unable or unwilling to receive infusions at Morgan Stanley Children's Hospital.
Contact & Investigator
Prakash Satwani, MD
PRINCIPAL INVESTIGATOR
Professor of Pediatrics
Frequently Asked Questions
Who can join the NCT06926894 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 26 Years, studying Epstein-Barr Virus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06926894 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06926894 currently recruiting?
Yes, NCT06926894 is actively recruiting participants. Contact the research team at ps2087@cumc.columbia.edu for enrollment information.
Where is the NCT06926894 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06926894 clinical trial?
NCT06926894 is sponsored by Columbia University. The principal investigator is Prakash Satwani, MD at Professor of Pediatrics. The trial plans to enroll 18 participants.