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T-Cell Therapy for Cytomegalovirus Infection After Stem Cell Transplant

This study is looking at a new way to treat cytomegalovirus (CMV) infections in people who have had a stem cell transplant. CMV is a common virus that can cause serious problems, especially in people with weakened immune systems. Researchers are testing a treatment called CMV-specific adoptive T-cells. These are special immune cells taken from a donor's blood, selected to fight CMV, and then given to the patient. The goal is to see if this treatment is possible and safe, and if it can help clear up CMV infections. You might be able to join if you've had an allogeneic (donor) stem cell transplant and have a CMV infection or the virus is active in your body.

Study design
This is an interventional study, meaning participants will receive a treatment. It will include a single group of about 20 participants.
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 your transplant.

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

NCT02982902

T Cell Therapy of Opportunistic Cytomegalovirus Infection

Recruiting
EARLY_PHASE1Ages 3+InterventionalSupportive care
Mari Dallas
~20 participants
Updated 2025-10-22 on ClinicalTrials.gov
What's tested:CMV specific adoptive 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
Incidence of adverse events
Measured over Up to 100 days after transplant

Conditions

Cytomegalovirus Infections
Hematopoietic Stem Cell Transplant
Opportunistic Infections

Explore related trials

Cytomegaloviral InfectionHematopoietic Cell TransplantationCytomegaloviral InfectionHLA Complex

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Mari H Dallas, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Who to contact

Mari H Dallas, MD
[email protected]
1-800-641-2422
Email the study team

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Eligibility criteria

Inclusion

Patients must have received allogeneic hematopoietic stem cell transplant and be greater than 30 days post-transplant at the time of registration
Patients must have documented opportunistic CMV infection, or reactivation; the criteria include (both of the following criteria must be met)
Patients may have asymptomatic viremia (\>1000 copies/ml) OR presence of symptoms secondary to CMV infection, AND
Patients must have ONE OF THE NEXT FOUR CRITERIA:
Absence of an improvement of viral load after ≥ 14 days of antiviral therapy with ganciclovir, valganciclovir or foscarnet (decrease by at least 1 log, i.e. 10-fold) or
New, persistent and/or worsening CMV-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 or foscarnet.
Second recurrence of CMV viremia, CMV-related symptoms, signs and/or markers of end organ compromise.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3
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 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.
Patients with opportunistic viral infections other than CMV.
Patients with active, grade 2-4, acute graft vs. 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.
Related donor of T cells must be at least partially HLA compatible, matching with recipient in at least 3/6 HLA loci (HLA-A, HLA-B, and HLA-DRB1 loci will be considered for this).
Must have evidence of a serologic response (i.e. be seropositive) against CMV.
Age ≥ 18 years
Must meet the criteria for donor selection defined in the Standard Operating Procedures of University Hospitals Seidman Cancer Center Stem Cell Transplant Program
Must be capable of undergoing a single standard 2 blood volume leukapheresis or donation of one unit of whole blood

What this trial measures

  • Incidence of adverse eventsUp to 100 days after transplant

    To determine the feasibility of the intervention, the study will record the incidence of adverse events, including graft versus host disease and other complications will be evaluated using binomial distribution theory and their 95% confidence intervals (CIs) will be also estimated using Wilson's method