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
  • Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-BCMA-101 in Subjects with Relapsed / Refractory Multiple Myeloma (MM) Followed by a Phase 2 Assessment of Response and Safety (PRIME)

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • 2019-116
    NCT ID
    • NCT03288493
    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
    Principal Investigator
    • Abhinav
      Deol, M.D.

      Oncology - Hematology, Oncology - Medical View Profile

    Objective:

    Primary Objectives:
    • Phase 1: To determine the safety and maximum tolerated dose (MTD) of PBCMA101 based on dose limiting toxicities (DLT)
    • Phase 2: To assess the safety and efficacy of PBCMA101

    Secondary Objectives:
    • Phase 1:
      1. The safety and feasibility of P-BCMA-101
      2. The anti-myeloma effect of P-BCMA-101
      3. The effect of cell dose to guide selection of doses for further assessment in Phase 2/3 studies

    • Phase 2:
      1. Incidence and severity of cytokine release syndrome (CRS)
      2. Additional efficacy endpoints
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

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