A phase 1b study of SEA-BCMA in patients with relapsed or refractory multiple myeloma

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Overview

This trial is testing a monoclonal antibody called SEA-BCMA. Researchers want to know what dose is safest, what side effects patients may have, and if SEA-BCMA will work to treat multiple myeloma.

SEA-BCMA is a type of treatment called a monoclonal antibody. Antibodies are part of your immune system. Usually, they help protect you from getting sick. With SEA-BCMA, researchers are using an antibody designed to stick to the multiple myeloma cells in your body. The antibody sends a signal to other cells in your immune system that kill the cancer cells. It also stops the multiple myeloma cells from getting a signal that makes them grow. The antibody may also stick to some non-cancer cells in your body.

They are asking you to be in this study because you have multiple myeloma that has come back or did not get better with your last therapy.

SparkCures ID 961
Trial Phase Phase 1
Enrollment 83 Patients
Treatments
Tags
Trial Sponsors
  • Seattle Genetics
NCT Identifier

NCT03582033

CLOSED

This trial is active but is no longer accepting patients.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Histologically confirmed diagnosis of MM
  • Must have MM that is relapsed or refractory
  • Has received a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody
  • Measurable disease, as defined by at least one of the following: (1) serum M protein 0.5 g/dL or higher, (2) urine M protein 200 mg/24 hour or higher, and (3) serum immunoglobulin free light chain (FLC) 10 mg/dL or higher and abnormal serum immunoglobulin kappa lambda FLC ratio.
  • Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1
  • Life expectancy of greater than 3 months in the opinion of the investigator
  • Adequate hematologic, renal, and hepatic function

Exclusion Criteria:

 

  • Prior treatment with a BCMA-directed therapy
  • History of another malignancy within 3 years
  • Active cerebral or meningeal disease related to the underlying malignancy
  • Uncontrolled Grade 3 or higher infection
  • Prior antitumor therapy that is not completed at least 4 weeks prior to first dose of study drug, or at least 2 weeks if progressing. Prior CAR-T-cell therapy must be completed 8 weeks before first dose of study drug.
  • Combination therapy only:
    1. Known intolerance to corticosteroids
    2. Uncontrolled psychoses

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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