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A Phase 1 Study of SEA-BCMA in Patients with Relapsed or Refractory Multiple Myeloma

Clinical Trial Details

This trial will study SEA-BCMA to find out whether it is an effective treatment for multiple myeloma (MM) and what side effects (unwanted effects) may occur.

The study will have two parts. In the first part, participants get SEA-BCMA by itself. This part of the study will find out how much SEA-BCMA should be given for treatment and how often. It will also find out how safe the treatment is and how well it works.

In the second part of the study, participants will be given both SEA-BCMA and dexamethasone. Dexamethasone is a drug that can be used to treat multiple myeloma. The part will study whether SEA-BCMA and dexamethasone are safe when used together.

Key Eligibility: 

Inclusion Criteria:

  • Histologically confirmed diagnosis of multiple myeloma (MM)
  • Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1
  • Must have MM that is relapsed or refractory and must not have other therapeutic options available known to provide clinical benefit in MM
  • Has received a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody
  • Life expectancy of greater than 3 months in the opinion of the investigator
  • Patients of childbearing potential or who can father children must agree to consistently use 2 effective forms of birth control for at least 6 months after the final dose of study drug administration
  • Adequate hematologic, renal, and hepatic function
  • Measurable disease

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 the first dose of study drug, or at least 2 weeks if progressing. Prior CAR T-cell therapy must be completed 8 weeks before the first dose of study drug.
  • Patients who are pregnant or breastfeeding
  • Combination therapy only: Known intolerance to corticosteroids; uncontrolled psychoses 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Kathleen Pogonowski, RN
(646) 962-6500
kap9111@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1808019540

ClinicalTrials.gov:

NCT03582033

Sponsor:

SGNBCMA-001

Status

Open to Enrollment

Age Group

Adult

Sponsor