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 Study Evaluating SC291, a Hypoimmune, Allogeneic CD19-directed CAR T Cell Therapy, in Relapsed and/or Refractory B-cell Malignancies (ARDENT)

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • 2023-012
    NCT ID
    • NCT05878184
    Age Group
    • Adult
    • 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


    Primary Objectives:

    Evaluate safety and tolerability of SC291

    • Dose-limiting toxicities (DLTs)
    • Treatment-emergent adverse events (TEAEs)
    • Treatment-related adverse events (TRAEs)
    • Targeted adverse events (TAEs)
    • Adverse Events of Special Interest (AESIs)

    Secondary Objectives:

    Evaluate preliminary anti-tumor activity of SC291

    • Objective response
    • Duration of response (DOR)
    • Time to next treatment
    • Progression free survival (PFS)
    • Event free survival (EFS)
    • Overall survival (OS)

    Evaluate cellular kinetics and persistence of SC291

    • Cellular kinetics (CK)-related parameters evaluated by CAR copy number (CAR VCN): peak observed in peripheral blood after administration (Cmax), time of first occurrence of maximum-observed concentration (Tmax), terminal disposition phase half-life (t1/2), last observed quantifiable concentration in peripheral blood (Clast), time of last observed quantifiable concentration in peripheral blood (days) (Tlast), area under the concentration-time curves (AUCs)

    Evaluate host immunogenicity to SC291

    • Humoral immunogenicity assessment (anti-CD19-directed CAR)
  • Locations


    Karmanos Cancer Institute - Detroit Headquarters

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

    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266