NCT02982902 · Mari Dallas
T Cell Therapy of Opportunistic Cytomegalovirus Infection
What this study is about
The purpose of this study is to determine if a specific type of cell-based immunotherapy, using T-cells from a donor that are specific against cytomegalovirus (CMV) is feasible to treat infections by CMV. Adoptive T-cell therapy is an experimental (experimental) therapy that works by using the blood of a donor and selecting the T-cells that can respond against a specific infectious entity.
View original scientific description
The purpose of this study is to determine if a specific type of cell-based immunotherapy, using T-cells from a donor that are specific against cytomegalovirus (CMV) is feasible to treat infections by CMV. Adoptive T-cell therapy is an investigational (experimental) therapy that works by using the blood of a donor and selecting the T-cells that can respond against a specific infectious entity. These selected T-cells are then infused to the patient, to try to give the immune system the ability to fight the infection. Adoptive T-cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA).
Interventions
BIOLOGICAL
CMV specific adoptive t-cells
It is expected that the cell dose will be in the range of 10\^3 - 10\^5 virus - specific, antigen selected T cells per kg of recipient weight.
Primary outcome measures
Incidence of adverse events
Time frame: Up 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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. Donor eligibility
- 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
Where
- Cleveland, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 22, 2025 · Source of record for eligibility and locations