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Phase 1 study of SGN-CD352A in patients with relapsed or refractory multiple myeloma

Clinical Trial Details

  • This study is for men and women with relapsed or refractory multiple myeloma, who have had at least two prior anti-myeloma regimens. 
  • This study is being done to test if SGN-CD352A is safe to give to patients with myeloma, and will test what the best dose of SGN-CD352A is for myeloma patients. SGN-CD352A is a type of drug called an antibody drug conjugate, or ADC. ADCs usually have 2 parts: a part that targets cancer cells (the antibody) and a cell-killing part (the chemotherapy). The antibody part of SGN-CD352A sticks to a target called CD352. CD352 is an important part of some cancer cells and some normal cells of the immune system. The antibody part of SGN-CD352A sticks to a target called CD352. CD352 is an important part of some cancer cells and some normal cells of the immune system. The cell-killing part of SGN-CD352A is a chemotherapy called SGD-1882. Once the antibody part of SGN-CD352A sticks to CD352 on the myeloma cell, the ADC goes inside the cell. There the chemotherapy is released and kills the cell. SGN-CD352A has been given to animals, however this research study is the first using SGN-CD352A in people. 
  • SGN-CD352A will be dosed intravenously (IV) every 4 weeks (Day 1 of a 28 day cycle). The initial part of the study will consist of a dose escalation in order to estimate the maximum tolerated dose of SGN-CD352A. Your dose will vary depending on what cohort you are in; it can range from 8 mcg/kgm, to 65 mcg/kg. Once dose escalation is completed and safety of the drug has been demonstrated, expansion cohorts will be enrolled to 2 dose levels to further evaluate safety and antitumor activity. Patients stay on study until their disease progresses, they have a unacceptable toxicity, the patient’s doctor believes it’s in the patient’s best interest to be removed from the study, or the patient decides to withdraw their consent for the study. 
Key Eligibility: 
  • Men and women age 18 and older 
  • A confirmed diagnosis of symptomatic multiple myeloma and measureable secretory disease 
  • ECOG performance score of 0 or 1 
  • At least 2 prior anti-myeloma regimens that you responded to, with a regimen that included a proteasome inhibitor and immunomodulatory agent (IMiD) 
  •  Detailed eligibility reviewed when you contact the study team 

Contact

Linda Tegnestam
lit2011@med.cornell.edu
646-962-6500

Primary Investigator

Ruben Niesvizky, M.D.

Protocol ID(s)

Weill Cornell Medicine IRB #:

1608017460

ClinicalTrials.gov:

NCT02954796

Status:

Open to Enrollment

Age Group

Adult

Sponsor

Drug/Device

Drug

Study Type

Phase

1