Adoptive Transfer of pp65-specific T Cells for the Treatment of Refractory Cytomegalovirus (CMV) Infection

Yae-Jean Kim

Overview

To evaluate the safety and efficacy for treatment of persistent CMV infection in hematopoietic cell transplant (HCT) recipients.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Cytomegalovirus Infections

Interventions

IFN-γ positive selected T-cellsBIOLOGICAL

No intervention

Eligibility

Sex: ALLMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Seoul, Gangnam-Gu, South Korea

Outcomes

Primary Outcomes

Level of enriched IFN-Υ+ T-cells upon pp65 stimulation

Time frame: 2 weeks

Secondary Outcomes

Treatment efficacy of CMV infection, defined as reduction of CMV viremia, ex vivo enrichment of CMV antigen (pp65) -specific T cells in peripheral blood.

Treatment efficacy defined as reduction of CMV viremia, ex vivo enrichment of CMV antigen (pp65) -specific T cells in peripheral blood.

Time frame: 2 weeks

Data from ClinicalTrials.gov

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