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
Trial Description
The purpose of this study is to assess BMS-986453 in participants with relapsed and/or
refractory multiple myeloma (RRMM).
Eligibility Requirements
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 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 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.