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RECRUITING
NCT05183490
PHASE1

R-MVST Cells for Treatment of Viral Infections

Sponsor: Columbia University

View on ClinicalTrials.gov

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.

Official title: Phase I Study of Adoptive Immunotherapy of Refractory Viral Infection with Ex Vivo Expanded Rapidly Generated Virus Specific T (R-MVST) Cells

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2022-05-03

Completion Date

2026-12

Last Updated

2024-12-30

Healthy Volunteers

No

Interventions

DRUG

Rapidly generated virus specific T (R-MVST) cells

The R-MVST products will be manufactured individually for each patient from a selected donor; it is an anti-viral prophylaxis and treatment of viral reactivation. SCT dose escalation: Cohort / R-MVST dose * (-1A) 0.25x10\^6 R-MVST TNC/kg * (1A) 0.5x10\^6 R-MVST TNC/kg * (2A) 1x10\^6 R-MVST TNC/kg SOT dose escalation: Cohort / R-MVST dose * (-1B) 1x10\^6 R-MVST TNC/kg * (1B) 2x10\^6 R-MVST TNC/kg * (2B) 4x10\^6 R-MVST TNC/kg

Locations (1)

Columbia University Irving Medical Center

New York, New York, United States