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The Molecular Mechanism of CMV-driven NKG2C+NK Cell Expansion in Human

Sponsor
Peking University People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04298502
Collaborator
(none)
40
Enrollment
1
Location
24
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an observation study to investigate the molecular mechanism of NKG2C+NK cell expansion after HCMV infection

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    According to the changes of molecular and gene expression in NK cells at different time points after infection, we want to find out the mechanism by which HCMV promotes the expansion of NKG2C + NK cells.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Molecular Mechanism of CMV-driven NKG2C+NK Cell Expansion in Human
    Actual Study Start Date :
    Jan 1, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2020
    Anticipated Study Completion Date :
    Dec 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. CMV viremia [2 moths post-transplantation]

      CMV-DNA>1.0x10^3 cpies/mL

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation

    2. No severe organ dysfunction or failure

    3. Subjects must be capable of, and willing to provide written informed consent to participate in the study. Subjects unable to provide written informed consent by themselves may be consented through their legal representative.

    Exclusion Criteria:

    1. Participation in another industry-sponsored clinical study where treatment for CMV is already specified by the study protocol.

    2. Patients received other adoptive immunotherapy such as donor lymphocyte infusion (DLI), Epstein-Barr virus (EBV)-specific T cells and so on.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Institute of Hematology Beijing Beijing China 100044

    Sponsors and Collaborators

    • Peking University People's Hospital

    Investigators

    • Study Chair: Xiaojun Huang, M.D., PhD, Peking University People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiaojun Huang,MD, Head of Peking University Institute of Hematology, Peking University People's Hospital
    ClinicalTrials.gov Identifier:
    NCT04298502
    Other Study ID Numbers:
    • HCMV-NKG2C+ NK cell
    First Posted:
    Mar 6, 2020
    Last Update Posted:
    Oct 1, 2020
    Last Verified:
    Sep 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Viremia

    Study Results

    No Results Posted as of Oct 1, 2020