Virus Specific Immune Lymphocytes (Virus-CTL) in the Treatment of Opportunistic Viral Diseases Post Transplantation


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Primary Outcome Measures:

  • Using CTCAE 4 standard to evaluate the level of adverse events after receiving autologous or allogenic virus-CTL infusion [ Time Frame: 24 weeks ]

    to evaluate the level of adverse events with CTCAE 4

  • viral load change after CTL infusion [ Time Frame: 3 months ]

    The viral load response to the CTL infusion will be assessed by CMV/EBV specific PCR of peripheral blood everyday after infusion.

Secondary Outcome Measures:

  • The incidence of Ⅱ~Ⅳ°aGVHD within 30 days after the last dose of CTL infusion [ Time Frame: 1 months ]
  • Reconstitution of antiviral immunity monitored by flow cytometry [ Time Frame: 6 months ]
  • Number of patients with chronic GVHD [ Time Frame: 6 months ]

Background:

Opportunistic infection virus related diseases are major causes of transplant-related morbidity and mortality in immunosuppressed patients, especially in the early post-transplant period. CMV, EBV, adenovirus (ADV), BK virus (BKV) and other viruses after transplantation, which may lead to life-threatening infections.

Adoptive immunotherapy with cytotoxic T lymphocytes (CTLs) reactive with specific viral antigens has proven to be effective without stimulating acute graft-versus-host disease (GVHD) owing to the significantly reduced nonspecific alloreactivity. Here, the investigators aim to evaluate the safety and efficacy of multiple infusions of mix opportunistic infection virus peptide cytotoxic T lymphocytes cells in patients.

Objective:

Primary study objectives: Infusion of autologous or allogenic Virus-CTL to patients by I.V., to evaluate the safety.

Secondary study objectives: To evaluate the antiviral efficacy of IV-infused autologous or allogenic Virus-CTL cells.

Design:

Peripheral blood mononuclear cells (PBMC) will be obtained through apheresis. T cells from PBMC will be activated and enriched by dendritic cells with virus specific peptides. Cell preparation time is approximately 12-17 days. Subject will receive infusions of 1×105~4×106 cells/kg body weight of virus-CTL via IV infusion at 4 times. Patients are followed 1 week after the final infusion, monthly for 3 months, and then every 3 months until the trial ends.