T Cell Therapy of Opportunistic Cytomegalovirus Infection
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age3+
SponsorMari Dallas
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
CMV specific adoptive t-cells
Biological/VaccineIt 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: CMV specific adoptive t-cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of adverse events
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
Time frame
Up to 100 days after transplantSecondary outcomes
1
Eradication rate of opportunistic CMV infections
The eradication rate will be the disappearance of opportunistic CMV infections with the use of CMV-specific, antigen-selected T cells using the CliniMACS Prodigy System over the total number CMV infections.
Time frame
Up to 100 days after transplant2
response rate
A response rate of 25% is considered unacceptable; and the anticipated response rate is approximately 55% for the study population using the cell therapy.
Time frame
Up to 100 days after transplantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mari Dallas
Lead sponsor
Case Comprehensive Cancer Center
Sponsor institution
Source ClinicalTrials.gov