R-MVST Cells for Treatment of Viral Infections in Children and Young Adults
Single Center Phase I Study of Adoptive Immunotherapy of Refractory Viral Infection With ex Vivo Expanded Rapidly Generated Virus Specific T (R-MVST) Cells for Immunodeficient Children and Young Adults
Monica Bhatia
18 participants
Apr 20, 2025
INTERVENTIONAL
Conditions
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
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Interventions
Group A dose escalation schedule: * Cohort (-1A): 0.25x10\^6 R-MVST TNC/kg * Cohort (1A): 0.5x10\^6 R-MVST TNC/kg * Cohort (2A): 1x10\^6 R-MVST TNC/kg Groups B \& C dose escalation schedule: * Cohort (-1B) + (-1C): 1x10\^6 R-MVST TNC/kg * Cohort (1B) + (1C): 2x10\^6 R-MVST TNC/kg * Cohort (2B) + (2C): 4x10\^6 R-MVST TNC/kg
Locations(1)
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NCT06926894