A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma

Juno Therapeutics

Status and phase

Enrolling

Phase 1

Conditions

Relapsed and/or Refractory Multiple Myeloma

Treatments

Drug: Cyclophosphamide

Drug: Fludarabine

Drug: BMS-986453

Study type

Interventional

Funder types

Industry

Identifiers

2023-506003-26-00 (Other Identifier)

CA119-0002

Details and patient eligibility

About

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

Enrollment

187 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.