Actively Recruiting
R-MVST Cells for Treatment of Viral Infections
Led by Columbia University · Updated on 2024-12-30
36
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
R-MVST Cells for Treatment of Viral Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years or older of any ethnic group
- History of hematopoietic cell transplant or solid organ transplant with viral reactivation or infection from EBV, CMV, ADV, or BK virus causing end-organ or systemic disease
- Suboptimal response to standard care therapy for viral infection
- Recurrent or multiple viral infections/reactivations requiring intervention or causing symptoms, with at least one virus meeting refractory criteria
You will not qualify if you...
- Uncontrolled infections other than CMV, EBV, ADV, or BK virus
- For bacterial infections, must have no progressing infection signs for 72 hours prior to infusion while on therapy
- For fungal infections, must be on systemic antifungal therapy with no progressing infection for 1 week prior to infusion
- Receiving corticosteroids at doses equal to or above 0.5 mg/kg prednisone or equivalent
- Received anti-thymocyte globulin, alemtuzumab, or other T-cell suppressive antibodies within last 28 days
- Received methotrexate or other toxic antimetabolite immunosuppressants within last 7 days
- Received extracorporeal photopheresis within last 28 days
- Received checkpoint inhibitor agents within 3 drug half-lives before infusion
- Received donor lymphocyte infusion within last 28 days
- Evidence of graft-versus-host disease grade 2 or higher
- Biopsy-proven acute rejection in solid organ transplant recipients
- Active uncontrolled relapse of malignancy
- Pregnant or breastfeeding
- Female of childbearing potential or male with female partner of childbearing potential unwilling to use effective contraception
- Uncontrolled intercurrent illness including symptomatic heart failure, unstable angina, arrhythmia, or psychiatric illness/social situations limiting compliance
- Received investigational product within 14 days prior to R-MVST infusion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
N
Nurse Navigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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