Phase 1 Study of SGN-CD352A in Patients With Relapsed or Refractory Multiple Myeloma

This study tests the safety of a drug called SGN-CD352A, to find out what its side effects are. SGN-CD352A will be given every 4 weeks to a small group of patients with multiple myeloma.
Cancer (Oncology), Cancer (Oncology) - Multiple Myeloma
William Bensinger, MD
Swedish Cancer Institute
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of MM requiring systemic therapy (per the International Myeloma Working Group [IMWG] ).
  • Age 18 years or older.
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤1.
  • Life expectancy >3 months.
  • Received at least 2 prior lines of therapy for MM including an immunomodulatory drug and a proteasome inhibitor.
  • Measurable disease, as defined by at least one of the following:

    • Serum M protein ≥0.5 g/dL
    • Urine M protein ≥200 mg/24 hr
    • Abnormal serum free light chain (SFLC) ratio.
  • Adequate hematologic, renal, and hepatic function
  • A negative pregnancy test (for females of childbearing potential).
  • Patients must provide written informed consent.

Exclusion Criteria:

  • Other invasive malignancy within the past 3 years.
  • Active cerebral/meningeal disease related to the underlying malignancy.
  • Active Grade 3 or higher infection.
  • Known to be positive for HIV or known to have active hepatitis B or C
  • Previous allogeneic stem cell transplant.
  • Idiopathic interstitial pneumonia or impaired diffusion capacity of the lung for carbon monoxide (DLCO)
  • Cerebrovascular or cardiovascular event, or congestive heart failure within the last 6 months.
  • Females who are pregnant or breastfeeding.
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