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.
- 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.
- 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.
Johns Hopkins University / Sidney Kimmel Cancer Center
Trial Phase Phase I
Trial Type Treatment
Corvus Pharmaceuticals, Inc.
- Primary ID CPI-444-003
- Secondary IDs NCI-2020-02214
- Clinicaltrials.gov ID NCT04280328