R-MVST Cells for Treatment of Viral Infections in Children and Young Adults

Launched by COLUMBIA UNIVERSITY · Apr 8, 2025

Keywords

ClinConnect Summary

The clinical trial titled "R-MVST Cells for Treatment of Viral Infections in Children and Young Adults" is exploring a new approach to treat children and young adults with severe viral infections caused by Epstein-Barr Virus (EBV), cytomegalovirus (CMV), adenovirus (ADV), or BK virus. The main goal is to see if a special type of immune cells, called R-MVST cells, can be safely given to patients who have had little success with standard treatment. The cells are made from healthy donors who are a good match for the patients. Throughout the study, doctors will carefully monitor participants for any potential side effects.

To be eligible for this trial, participants should be between 3 months and 25 years old and have a history of certain medical treatments (like stem cell or organ transplants) along with evidence of these viral infections that did not respond well to regular therapies. However, there are some criteria that could prevent individuals from participating, such as having other serious infections or certain health conditions. If they do qualify, participants can expect close monitoring by healthcare professionals and assessments of how well the treatment works in reducing the viral infections and improving their overall health. This trial is not yet recruiting participants, but it represents a hopeful step in finding new ways to help young patients with challenging viral infections.

Gender

ALL

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.