RecruitingPhase 1NCT06153251
A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma
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
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Enrollment
187 participants
Start Date
Jan 23, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 and in Part B Cohort 2 must have relapsed/refractory multiple myeloma and received previous antimyeloma therapy, including a proteasome inhibitor and an immunomodulatory agent.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Participants must have adequate organ function.
Exclusion Criteria3
- 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.
Interventions
DRUGBMS-986453
Specified dose on specified days
DRUGFludarabine
Specified dose on specified days
DRUGCyclophosphamide
Specified dose on specified days
Locations(19)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06153251