Immune cells from donors take on viruses in transplant patients
NCT ID NCT03665675
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests whether immune cells from a donor can safely fight cytomegalovirus (CMV) or adenovirus (AdV) infections in people who have had a stem cell or solid organ transplant. About 20 participants will receive these virus-specific T-cells intravenously. The main goals are to check for side effects and see if the treatment can control the virus.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- donor virus-specific T-cells (CMV or adenovirus)
- What this could lead to
- If it works, this could offer a new way to control serious viral infections after organ or stem cell transplants, reducing the need for antiviral drugs.
- What could go wrong
- This is a very early, small pilot study (20 people). It may not work for everyone, and there are risks like graft-versus-host disease or infusion reactions.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2020
- Expected to finish
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Dec 2026
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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1 year to 85 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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.
Inclusion Criteria: * Patients must have solid organ transplant or have received allogeneic hematopoietic stem cell transplant. * • Cohort A (CMV): Must have documented CMV disease or reactivation, as by: * Viremia as detected by quantitative polymerase chain reaction (PCR) (\> 500 IU/ml) in the peripheral blood requiring treatment OR * High risk for antiviral failure due to history of recurrent CMV reactivations or evidence of antiviral drug resistance, OR * Unable to tolerate antiviral drugs due to renal toxicity, bone marrow suppression, transfusion dependent anemia and thrombocytopenia or neutropenia requiring growth factor support or other related organ injury • Cohort B (AdV): Must have documented AdV infection or reactivation, as by: * Symptomatic subject with any detectable viral load in blood, OR * Symptomatic subject with qualitative AdV detection in compartment of current symptomatology, including stool, urine, and/or other specimens (bronchoalveolar lavage (BAL), nasal swab, CSF, etc.), irrespective of blood viral load, OR * New, persistent, and/or worsening AdV-related symptoms, signs, and/or markers of end organ compromise while receiving antiviral therapy (ie cidofovir), OR * Asymptomatic with a viral load \> 1000 copies/ml in peripheral blood, OR * Unable to tolerate antiviral treatment due to renal toxicity, bone marrow suppression, transfusion dependent anemia and thrombocytopenia or neutropenia requiring growth factor support or other related organ injury * Karnofsky (age \> 16 years) or Lansky performance score \> 70 (age \< 16) * Available seropositive haploidentical or matched donor who is without evidence of infection that would otherwise preclude donation * Negative pregnancy test in female patients if applicable (childbearing potential, has not received a full-intensity conditioning regimen * Written informed consent and/or signed assent line from patient, parent or guardian * DONOR * Human leukocyte antigen (HLA)-haploidentical or full-match to the patient as determined by institutional standards * Cohort A: CMV seropositive, defined as detection of serum CMV immunoglobulin G (IgG) * Cohort B: AdV seropositive, defined as detection of serum AdV IgG * Age 18 or over * Meet donor eligibility or suitability according to institutional standards. If the donor is deemed ineligible according to Foundation for the Accreditation of Cellular Therapy (FACT) standards, but is suitable for donation per institutional standards, the donor will be eligible for the protocol Exclusion Criteria: * Receipt of anti-thymocyte globulin (ATG), alemtuzumab, or other T-cell depleting agents within 21 days of screening for enrollment. * Receipt of \> 0.5mg/kg/day of prednisone or steroid equivalent at the time of enrollment. Stable GVHD is permitted as long as patients are on stable dose steroids of less than or equal to 0.5 mg/kg/day of prednisone or steroid equivalent. * Evidence of uncontrolled infection as follows: * Bacterial infections - patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. * Fungal infections - patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. * Patients with hemodynamic instability attributable to bacterial sepsis or new symptoms, worsening physical signs or radiographic findings attributable to concomitant bacterial or fungal infection are excluded. Patients who require ventilator support for CMV pneumonitis are not excluded. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. * Receipt of donor lymphocyte infusion (DLI) within 28 days. * Patients with active acute graft versus host disease (GvHD) grades II-IV requiring \> 0.5 mg/kg/day of prednisone or steroid equivalent or T-cell depleting immunosuppression. * Acute graft rejection in solid organ transplantation requiring augmented immunosuppression with T-cell depleting agents or steroids as mentioned above. * Active and uncontrolled relapse of malignancy.
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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
2 sites. 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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Nationwide Children's Hospital
RECRUITINGColumbus, Ohio, 43205, United States
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Ohio State University Comprehensive Cancer Center
SUSPENDEDColumbus, Ohio, 43210, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- The Little-Known virus that may rival RSV and flu in older adults
- Vitamin a boost before stem cell transplant may shield the gut
- Can we outsmart Drug-Resistant CMV in transplant patients?
- Can specially grown immune cells from donors beat viruses that won't go away?
- Blood test may one day personalize drug dosing after stem cell transplants
- Lab-Grown immune cells take aim at Life-Threatening viruses in vulnerable patients