Antigen Specific Adoptive T Cell Therapy for Adenovirus Infection After Hematopoietic Stem Cell Transplantation

This study is testing an experimental treatment called antigen specific adoptive T cell therapy for adenovirus (HAdV) infections in patients who have received an allogeneic hematopoietic stem cell transplant (a transplant using cells from a donor). This therapy uses special immune cells, called T cells, from a donor who is immune to the adenovirus. These T cells are selected and then given to the patient to help their immune system fight the infection. The main goals are to see if this treatment is possible and to understand any side effects. You might be able to join if you've had an allogeneic stem cell transplant, are at least 30 days post-transplant, and have a documented HAdV infection that hasn't responded to other treatments or if you can't take those treatments. The study aims to enroll 20 participants, but the current recruitment status is unclear.

Study design: This is a feasibility study with a single treatment group, aiming to enroll 20 participants. Patients will be enrolled one at a time to ensure safety.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Your safety will be monitored for up to 100 days after receiving the T cell infusion.

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Antigen Specific Adoptive T Cell Therapy for Adenovirus Infection After Hematopoietic Stem Cell Transplantation

Recruiting

EARLY_PHASE1Ages 3+InterventionalSupportive care

Mari Dallas

~20 participants

Updated 2026-06-04 on ClinicalTrials.gov

What's tested:IFN-gamma-secreting HAdV antigen specific T 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

Number of patients with severe adverse events

Measured over Up to 100 days after infusion

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation

Where it's being run

1 sites across 1 states

Ohio1

Study leadership

Mari H Dallas, MD · PRINCIPAL_INVESTIGATOR · University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center

Who to contact

Mari H Dallas, MD

[email protected]

216-844-0139

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Eligibility criteria

Inclusion

Patients must have received allogeneic HSCT and be greater than 30 days post-HSCT at the time of registration.

Patients must have evidence of documented HAdV infection/reactivation. Patients may be:

Symptomatic with any detectable viral load OR

Asymptomatic with viral load that is:

Patients must have poor response and/or contraindication to therapy:

Absence of an improvement of viral load (decrease by at least 1 log, i.e. 10-fold) after ≥ 14 days of antiviral therapy with ganciclovir, valganciclovir and/or foscarnet. OR

New, persistent and/or worsening HAdV-related symptoms, signs and/or markers of end organ compromise while on antiviral therapy with ganciclovir, valganciclovir or foscarnet. OR

Have contraindications or experience adverse effects of antiviral therapy with ganciclovir, valganciclovir, cidofovir or foscarnet.

Performance Score: Eastern Cooperative Oncology Group (ECOG) Performance Score ≤ 3. Karnofsky (≥ 16 years) or Lansky (\<16 years) performance score ≥ 50

The effects of virus-specific, antigen-selected T cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 4 weeks prior to study entry, for the duration of study participation and for 3 months after completing treatment.

Subjects who are 14 years and older must have the ability to understand and the willingness to sign a written informed consent document, or assent document.

Exclusion

Pregnant or breastfeeding women are excluded from this study. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with the agents described above, breastfeeding should be discontinued if the mother participates in this trial.

Patients with opportunistic viral infections other than HAdV.

Patients with active, grade II-IV, acute graft versus host disease (GVHD), chronic GVHD or any condition requiring high doses of glucocorticosteroid (\>0.5 mg/kg/day prednisone or its equivalent) as treatment.

Treatment with antithymocyte globulin within 28 days of planned infusion of virus - specific, antigen selected T cells.

Treatment with virus - specific T cells within 6 weeks (42 days) of planned infusion.

What this trial measures

Number of patients with severe adverse eventsUp to 100 days after infusion
This is a measure of feasibility: Severe adverse events are related to the infusion of virus-specific, antigen selected T cells, Grade ≥ 3 acute graft versus host disease,• Death within 30 days of the infusion of the virus-specific, antigen selected T cells that is considered by the investigators to be probably or possibly related to the T cell infusion

Trialytics