T Cell Therapy of Opportunistic Cytomegalovirus Infection

Recruiting now · Early Phase 1

Conditions studied: Cytomegalovirus Infections, Hematopoietic Stem Cell Transplant, Opportunistic Infections

In brief

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).

Key facts

Study ID

NCT02982902

Run by

Mari Dallas

People needed

20

Starts

2020-05-27

Expected to finish

2028-08-01

Last updated by the study team

2025-10-22

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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