R-MVST Cells for Treatment of Viral Infections in Children and Young Adults
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.
Timeline
- Start
- 2025-04-20
- Primary completion
- 2029-04
- Completion
- 2030-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rapidly generated virus specific T (R-MVST) cells | Cell therapy | 250000 cells/kg | — |
| Subject | Rapidly generated virus specific T (R-MVST) cells | Cell therapy | 500000 cells/kg | — |
| Subject | Rapidly generated virus specific T (R-MVST) cells | Cell therapy | 1e+06 cells/kg | — |
| Subject | Rapidly generated virus specific T (R-MVST) cells | Cell therapy | 2e+06 cells/kg | — |
| Subject | Rapidly generated virus specific T (R-MVST) cells | Cell therapy | 4e+06 cells/kg | — |