RecruitingPhase 1NCT05183490

R-MVST Cells for Treatment of Viral Infections

Phase I Study of Adoptive Immunotherapy of Refractory Viral Infection With ex Vivo Expanded Rapidly Generated Virus Specific T (R-MVST) Cells

Sponsor

Columbia University

Enrollment

36 participants

Start Date

May 3, 2022

Study Type

INTERVENTIONAL

Conditions

Epstein-Barr Virus Infections Cytomegalovirus Infections BK Virus Infection Adenovirus

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Rapidly generated virus specific T (R-MVST) cells for people with adenovirus, bk virus infection, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRapidly 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