R-MVST Cells for Viral Infections
Trial Summary
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, certain medications like corticosteroids at high doses, specific immunosuppressants, and investigational products must not have been taken recently. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the treatment R-MVST Cells for viral infections?
Is R-MVST cell therapy safe for humans?
While specific safety data for R-MVST cells is not available, similar therapies using engineered natural killer T cells have been shown to be safe in clinical trials for cancer, with no severe adverse events reported. These therapies have been well-tolerated in patients, suggesting a favorable safety profile.678910
How is the R-MVST Cells treatment different from other treatments for viral infections?
R-MVST Cells treatment is unique because it involves using specially modified cells to target viral infections, which may offer a more targeted approach compared to traditional antiviral drugs. This method could potentially provide a novel way to treat viral infections by harnessing the body's own immune cells.1112131415
What is the purpose of this trial?
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.
Research Team
Prakash Satwani, MD
Principal Investigator
Professor of Pediatrics
Eligibility Criteria
This trial is for children and young adults with stubborn viral infections like CMV, EBV, ADV, or BK virus. Participants must have a matching healthy donor available for T-cell donation. They should not have conditions that could worsen with the treatment.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive R-MVST cell infusions to treat viral infections
Follow-up
Participants are monitored for safety and effectiveness after treatment, including incidence of GVHD and other toxicities
Treatment Details
Interventions
- R-MVST Cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor