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Pilot Study of Haploidentical Donor Adenovirus Specific T-lymphocytes for Adenovirus Infections

This study is testing a treatment called Adenovirus Specific T lymphocytes (ADV-VSTs) for serious adenovirus infections that haven't responded to other treatments. These special immune cells come from a related donor. The study aims to see how safe ADV-VSTs are and if they can reduce the amount of virus in your body. You might be able to join if you are 60 years old or younger and have had an organ transplant or cancer treatment. The study is currently unclear on its recruitment status and plans to enroll 12 participants.

Study design
This is an open-label, single-arm study, meaning everyone receives the treatment and researchers know what treatment is given. It is a Phase I/II trial, which typically looks at safety and early effectiveness.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured between 7 and 28 days after treatment, and viral load will be measured at 28 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04722029

Pilot Study of Haploidentical Donor Adenovirus Specific T-lymphocytes to Treat Refractory Adenovirus Infections

Recruiting
PHASE1Up to 60InterventionalTreatment
Nationwide Children's Hospital
~12 participants
Updated 2025-05-13 on ClinicalTrials.gov
What's tested:Adenovirus Specific T lymphocytes

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety by measuring unacceptable toxicities
Measured over 7-28 days
+1 more outcome measured

Conditions

Adenovirus Infection

Explore related trials

Adenovirus Infection

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Eunkyung Song, MD · PRINCIPAL_INVESTIGATOR · Nationwide Children's Hospital

Who to contact

Melinda Triplet
[email protected]
6147226039
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 0 days to 60 years with one of the following conditions:
And must meet at least 1 of the following criteria.
Negative pregnancy test in female patients if applicable (childbearing potential)
Written informed consent and/or signed assent line from patient, parent or legal guardian prior to any study-related procedures.

Exclusion

Receipt of anti-thymocyte globulin (ATG), alemtuzumab, cytoxan, or other T-cell depleting drugs or monoclonal antibodies within 28 days from enrollment
Receiving corticosteroid (prednisone equivalent) ≥ 0.5mg/kg/day or ≥ 20mg/day at the time of enrollment
Recipients of allogeneic hematopoietic stem cell transplant (bone marrow, peripheral blood or umbilical cord blood)
Evidence of uncontrolled infection (except ADV) as follows:
Patient with poor performance status determined by Karnofsky (patients \>16 years) or Lansky (patients ≤16 years) score ≤30% (Table 5)
Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory adenovirus infection(s)
During the study, treatment with other investigational anti-adenoviral agents is prohibited until Week 12.
If patient has been treated with CMX001 (brincidofovir, BCV) prior to ADV-VST enrollment, BCV must be discontinued for at least 72 hours prior to ADV-VSTs infusion for washout based on known geometric mean elimination half-life of BCV (8 to 12 hours). Any medical condition which could compromise participation in the study according to the investigator's assessment
Known HIV infection
Female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment.
Known hypersensitivity to iron dextran
Patients unwilling or unable to comply with the protocol or unable to give informed consent.
Known human anti-mouse antibodies

What this trial measures

  • Safety by measuring unacceptable toxicities7-28 days

    Safety will be assess at 28 days post ADV-VSTS infusion. Safety is defined as presentation of unacceptable toxicities, measured by grade III-IV acute GVHD within 28 days, solid organ rejection/ graft failure within 28 days, grade \>4 infusional toxicity within 7 days of infusion, and grade 4-5 adverse events within 28 days per CTCAE 5.0.

  • Efficacy by measuring viral load28 days

    Percentage of patients with ≥1 log decrease in ADV viral load. ADV viral load will be monitored by quantitative ADV PCR weekly until negative PCR. Response will be assess on day 28 post ADV-VSTS infusion defined as complete response, partial response, stable disease or progressive disease