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A Phase 1, Open-Label, Dose-Finding Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma
Description
The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).
Trial Eligibility
Inclusion Criteria: * Participants must have a diagnosis of multiple myeloma with relapsed and/or refractory disease. * Participants must have confirmed progressive disease on or within 12 months (measured from the last dose) of completing treatment with the last anti-myeloma treatment regimen before study entry. * Participants in Part A and Part B Cohort 1 must have received at least 3 prior anti-myeloma treatment regimens, including a proteasome inhibitor and immunomodulatory agent. * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Participants must have adequate organ function. Exclusion Criteria: * Participants must not have any known active or history of central nervous system (CNS) involvement of multiple myeloma. * Participants must not have active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis. * Participants must not have a history or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or cerebellar disease, or presence of clinically active psychosis. Other protocol-defined inclusion/exclusion criteria apply
Study Info
Organization
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Primary Outcome
Number of participants with treatment-emergent adverse events (AEs)
Interventions
Locations Recruiting
University of Alabama at Birmingham
United States, Alabama, Birmingham
Local Institution - 0003
United States, California, Duarte
UCSF Helen Diller Medical Center at Parnassus Heights
United States, California, San Francisco
Stanford University Medical Center
United States, California, Stanford
Colorado Blood Cancer Institute
United States, Colorado, Denver
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