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

ENROLLING
Protocol # :
24-626
Conditions
Relapsed and/or Refractory Multiple Myeloma
Phase
I
Disease Sites
Multiple Myeloma
Principal Investigator
Mo, Clifton, C.
Site Research Nurses
Caron, Abigail
Kineavy, Brendan, E.
McHugh, Kristin, Mary
O'Donnell, Colin
Swenson, Emilie

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.

24-626