T Cell Therapy of Opportunistic Cytomegalovirus Infection
Antigen Specific Adoptive T Cell Therapy for Opportunistic Cytomegalovirus Infection Occurring After Stem Cell Transplant
Mari Dallas
20 participants
May 27, 2020
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria11
- 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 Criteria11
- 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
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Interventions
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.
Locations(1)
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NCT02982902