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R-MVST Cells for Treatment of Viral Infections

NCT05183490 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-12-30

No results posted yet for this study

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.

Conditions

  • Epstein-Barr Virus Infections
  • Cytomegalovirus Infections
  • Adenovirus
  • BK Virus Infection

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

Sponsors & Collaborators

Principal Investigators

  • Pawel Muranski, MD · Assistant Professor of Medicine and Pathology and Cell Biology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-03
Primary Completion
2025-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05183490 on ClinicalTrials.gov