Cytomegalovirus Infections
Conditions
Keywords
CMV, T cell therapy
Brief summary
To evaluate the safety and efficacy for treatment of persistent CMV infection in hematopoietic cell transplant (HCT) recipients.
Detailed description
HCT recipients who are receiving immunosuppressive agents to control graft versus host diseases (GVHD) are at high risk for serious CMV infection due to CMV reactivation or reinfection during their post-transplant period. Antiviral agents used to treat CMV infection have well-known side effects such as bone marrow suppression causing cytopenia and renal toxicities. Therefore, patients in a serious condition would have a higher probability of antiviral treatment-related toxicities and also increased possibility for prolonged antiviral treatment, thus development of antiviral resistance and risk of treatment failure. Allogeneic HCT recipients are typically lack of these CMV-specific T cells during the post-transplant period and their immune function can be further repressed especially when they are on additional immunosuppressive agents to prevent GVHD. Therefore, these patients may benefit from CMV-specific T cell adoptive transfer.
Interventions
BIOLOGICALIFN-γ positive selected T-cells
No intervention
Sponsors
Miltenyi Biotec B.V. & Co. KG
Yae-Jean Kim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 65 Years
Healthy volunteers
No
Inclusion criteria
* Less than 66 years old Allogeneic HCT recipients who received stem cells from related CMV positive serology donors * AND recipients have persistent CMV infection more than 2 weeks on antiviral treatment
Exclusion criteria
* HCT recipients with severe graft versus host disease, grade 3 or more * OR organ dysfunction (brain, heart, lung, liver, and kidney): altered mentality, extracorporeal membrane oxygenation, mechanical ventilator, increased liver enzymes 5 times above upper normal values, bilirubin level \>3 mg/dL, CrCl \< 30 mL/min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Level of enriched IFN-Υ+ T-cells upon pp65 stimulation | 2 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment efficacy of CMV infection, defined as reduction of CMV viremia, ex vivo enrichment of CMV antigen (pp65) -specific T cells in peripheral blood. | 2 weeks | Treatment efficacy defined as reduction of CMV viremia, ex vivo enrichment of CMV antigen (pp65) -specific T cells in peripheral blood. |
Countries
South Korea
Outcome results
None listed