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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)


Outcome Timeframe Up to 2 years

NCTID NCT06153251

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2024-01-23

Completion Date 2027-11-29

Enrollment Target 130

Interventions

DRUG BMS-986453

DRUG Fludarabine

DRUG Cyclophosphamide

Locations Recruiting

University of Alabama at Birmingham

United States, Alabama, Birmingham


City of Hope Comprehensive Cancer Center

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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