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

Yae-Jean Kim

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Cytomegalovirus Infections

Treatments: Biological: IFN-γ positive selected T-cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02346617

SMC 2010-08-129-008

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: Under 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

allogeneic HSCT

Experimental group

Description:

The present study will investigate in a single-center (Samsung Medical Center), open-label, single arm by direct infusions of donor-derived CMV-spefic IFN-γ positive T-cells for the treatment of refractory CMV infection in allogeneic hematopoietic stem cell transplant (HSCT) recipients.

Treatment:

Biological: IFN-γ positive selected T-cells