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Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma

Trial Status: Active

This is a Phase 1b open-label study of ciforadenant, an oral, small molecule inhibitor targeting adenosine-2A receptors (A2AR), on safety / tolerability and efficacy in combination with daratumumab, a monoclonal antibody targeting CD38, in relapsed or refractory multiple myeloma.

Inclusion Criteria

  • Relapsed or refractory myeloma.
  • Must have been exposed to at least 2 cycles of an IMiD containing regimen and PI containing regimen and must be refractory to at least one of the two.
  • Must have completed and tolerated 2 cycles of daratumumab or other anti-CD38 targeting antibodies.
  • Active myeloma requiring systemic treatment.
  • Measurable disease per protocol.
  • ECOG performance status of 0 - 2.
  • Life expectancy of at least 3 months.

Exclusion Criteria

  • POEMS syndrome; non-secretory myeloma (no measurable protein on sFLC assay); amyloidosis.
  • History of select prior malignancies.
  • Previous intolerance to daratumumab or any study drug.
  • Received an allogeneic stem cell transplant within 12 months, or an autologous stem cell transplant within 6 months, or have ongoing toxicity related to transplant.
  • Have an active infection or serious comorbid medical condition.
  • Any live attenuated vaccination against infectious diseases (e.g., influenza, varicella) within 4 weeks of initiation of study treatment; uncontrolled human immunodeficiency virus, or positive tests for hepatitis B or hepatitis C.
  • Female participants pregnant or breast-feeding.
  • Screening chemistry and blood counts within protocol limits
  • Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressant medication during study treatment.

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Corvus Pharmaceuticals, Inc.

  • Primary ID CPI-444-003
  • Secondary IDs NCI-2020-02214
  • Clinicaltrials.gov ID NCT04280328