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R-MVST Cells for Viral Infections After Transplant

This study is testing a new treatment called R-MVST cells for people who have viral infections after a stem cell or organ transplant. These infections, caused by viruses like Epstein-Barr (EBV), Cytomegalovirus (CMV), Adenovirus, or BK virus, can be serious when the immune system is weak. R-MVST cells are special immune cells made from a donor's blood that are designed to fight these specific viruses. The main goal is to see if R-MVST cells are safe and can be given to patients without causing too many side effects, especially a reaction called graft-versus-host disease (GVHD). The study will also look at whether the treatment helps reduce the amount of virus in the body and improves overall health. This study plans to enroll 36 participants and is currently recruiting.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is designed to test different doses of R-MVST cells in a small group of 36 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for safety and graft-versus-host disease for up to 28 days after receiving the R-MVST cell infusion.

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NCT05183490

R-MVST Cells for Treatment of Viral Infections

Recruiting
PHASE1Ages 18+InterventionalTreatment
Columbia University
~36 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:Rapidly generated virus specific T (R-MVST) cells

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of toxicity that leads to safety endpoint
Measured over Up to 28 days post R-MVST infusion
+1 more outcome measured

Conditions

Epstein-Barr Virus Infections
Cytomegalovirus Infections
Adenovirus
BK Virus Infection

Explore related trials

Adenovirus InfectionBK Virus InfectionCytomegaloviral InfectionEBV Infection

Where it's being run

1 sites across 1 states
New York1

Study leadership

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

Who to contact

Nurse Navigator
[email protected]
(212) 342 5162
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Eligibility criteria

Inclusion

Men and women ages 18 years or older of all ethnic groups will be eligible for the treatment
Patients with history of HCT or SOT who demonstrate evidence of viral reactivation and/or infection manifesting as end-organ or systemic disease due to one or more of the following viruses: EBV, CMV, ADV or BK virus and suboptimal response to the standard of care therapy.
Recurrent or Multiple Viral Infection. RVI defined as occurrence of more than one episode of reactivation that required intervention or symptomatic disease in recipient of allogeneic HCT that required standard of care treatment. MVI defined as more than one virus reactivating (defined by PCR positivity) or causing symptomatic systemic or end-organ disease. At least one of those viral reactivations required standard of care intervention. No standard of care therapy is defined for ADV and BK. Patients with multiple infections/reactivations will be eligible as long as at least one of those viral infections meet the criterium of "refractory".

Exclusion

Patients with other uncontrolled infections, except for CMV, EBV, ADV or BK. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to the day of infusion. For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to R-MVST infusion. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection
Patients who receive corticosteroids at ≥ 0.5mg/kg prednisone or equivalent.
Patients who received anti-thymocyte globulin (ATG, Alemtuzumab (Campath), or other T-Cell immunosupressive monoclonal antibodies in the last 28 days.
Patients who received methotrexate, or other antimetabolite-type immunosuppressants that are toxic to proliferating T cells in the last 7 days.
Patients who received extracorporeal photopheresis within the last 28 days.
Patients who received checkpoint inhibitor agents (e.g., nivolumab, pembrolizumab, ipilimumab) within 3 drug half-lives of the most recent dose to the infusion of R-MVST.
Received donor lymphocyte infusion in last 28 days.
Evidence of GVHD ≥ grade 2
Evidence of biopsy-proven acute rejection in SOT recipients
Active and uncontrolled relapse of malignancy
Patients who are pregnant, or breastfeeding.
Female of childbearing potential, or male with a female partner of childbearing potential, unwilling to use a highly effective method of contraception.
Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients who have received investigational (IND) product within 14 days of infusion of the the R-MVST cells.

What this trial measures

  • Incidence of toxicity that leads to safety endpointUp to 28 days post R-MVST infusion

    This is to measure the incidence of toxicity post-infusion. Toxicities to consider include: GI toxicity, renal toxicity, hemorrhagic toxicity, cardiovascular toxicity hypotension, cardiac arrhythmia and left ventricular systolic dysfunction), neurological toxicity (somnolence and seizure), coagulation toxicity, vascular toxicity and pulmonary toxicity.

  • Incidence of GVHD post-infusion that leads to safety endpointUp to 28 days post R-MVST infusion

    This is to measure the incidence of GVHD post-infusion. The safety endpoint will be defined as de novo acute GVHD grade IV within 28 days of the last dose of R-MVST, or grades 3-5 infusion related adverse events within 28 days of the last CTL dose, or grades 4-5 non-hematological adverse events within 28 days of the last CTL dose that are not due to the pre-existing infection or the original malignancy or pre-existing co-morbidities as defined by the N a t i o n a l C a n c e r I n s t i t u t e ( NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.