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

Last updated: March 18, 2020
Sponsor: Yae-Jean Kim
Overall Status: Trial Not Available

Phase

1/2

Condition

Cytomegalovirus Infections

Treatment

N/A

Clinical Study ID

NCT02346617
SMC 2010-08-129-008
  • Ages < 65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Less than 66 years old Allogeneic HCT recipients who received stem cells from relatedCMV positive serology donors

  • AND recipients have persistent CMV infection more than 2 weeks on antiviral treatment

Exclusion

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 5times above upper normal values, bilirubin level >3 mg/dL, CrCl < 30 mL/min

Study Design

Study Start date:
January 01, 2022
Estimated Completion Date:
December 01, 2024

Study 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.

Connect with a study center

  • Samsung Medical Center

    Seoul, Gangnam-Gu 135-710
    Korea, Republic of

    Site Not Available

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