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A Phase 1/2a Open-label, Dose-Escalation Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Patients with Relapsed/Refractory Multiple Myeloma

Clinical Trial Details

This is a phase 1/2a study designed to determine the safety and tolerability of TAK-079 monotherapy in women and men age 18 and older with relapsed or refractory multiple myeloma. TAK-079 is a fully human antibody that targets CD38+ leukocytes. TAK-079 treatment results in a rapid depletion of CD38. A number of hematologic tumors express CD38, including multiple myeloma (MM), acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia, chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma.

Subjects will receive TAK-079 via subcutaneous administration in each 28-day cycle of treatment, administered as once weekly for 8 weeks (8 doses), once every 2 weeks for 16 weeks (8 doses), and once every 4 weeks thereafter until disease progression. 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Kathleen Pogonowski, RN
212-746-6738
kap9111@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1801018901

ClinicalTrials.gov:

NCT03439280

Status

Open to Enrollment

Age Group

Adult

Sponsor