Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • A Phase 1 / 2 Study to Evaluate the Safety and Tolerability of Adoptively Transferred T Lymphocytes Targeting WT1, PRAME and Cyclin A1 in Patients with Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) Post Allogeneic Hematopoietic Cellula

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • 2020-004
    NCT ID
    • NCT04284228
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase I
    Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
    • Phase I/II
    Principal Investigator
    • Dipenkumar
      Modi, M.D.

      Oncology - Hematology, Oncology - Medical View Profile

    Objective:

    Primary Objective: To characterize the safety and tolerability of the adoptive cellular transfer of
    NEXI-001 T cells in patients

    Secondary Objectives:
    • To investigate the preliminary anti-tumor activity, as measured by ORR and response duration of NEXI-001 T cells using either the modified 2017 European Leukemia Net (ELN) Criteria (for AML)or modified 2006 IWG
    Response Criteria (for MDS)
    • To determine the efficacy of NEXI-001 T cells in patients as measured by PFS, OS and TTR
    • To measure the in vivo persistence and proliferation of NEXI001 T cells in blood and bone marrow samples
    • To establish the manufacturing feasibility, defined by the ability to produce and administer NEXI001 T cells
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266