Donor immune cells take on tough viruses in transplant patients
NCT ID NCT05183490
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests whether specially grown immune cells from a donor can safely help transplant patients fight off viral infections that standard treatments can't control. The cells target Epstein-Barr virus, cytomegalovirus, adenovirus, and BK virus. Up to 36 adults who have had a stem cell or organ transplant will receive an infusion of these cells, and researchers will watch closely for side effects like graft-versus-host disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rapidly generated virus specific T (R-MVST) cells
- What this could lead to
- If it works, this could offer a new treatment option for transplant patients with viral infections that don't respond to standard care.
- What could go wrong
- This is a very early Phase 1 trial with only 36 participants, focused on safety. The treatment may cause serious side effects like graft-versus-host disease, and it's too soon to know if it effectively controls infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2022
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Recipient Inclusion Criteria: * 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". Recipient Exclusion Criteria: * 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. Donor inclusion and exclusion criteria will be followed as per the most current BMT SOP (Donor selection, Donor evaluation and Donor Deferral).
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Columbia University Irving Medical Center
RECRUITINGNew York, New York, 10032, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Banked t cells target four viruses at once in children after transplant
- The Little-Known virus that may rival RSV and flu in older adults
- Can we outsmart Drug-Resistant CMV in transplant patients?
- Can we map CMV's spread in daycares to shield future pregnancies?
- Can cord blood t cells be trained to stop viral infections after transplant?
- Can immune cells predict herpesvirus danger in transplant patients?