Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

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

Official Title

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

Keywords

Relapsed and/or Refractory Multiple Myeloma, Dual Targeting, BCMAxGPRC5D, GPRC5DxBCMA, BMS-986453, CAR T, CART, Multiple Myeloma, Relapsed and/or Refractory, Plasma Cell Neoplasms, Cyclophosphamide, Fludarabine, Administration of BMS-986453

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

Locations

  • Local Institution - 0011 not yet accepting patients
    San Francisco California 94143 United States
  • Local Institution - 0006 not yet accepting patients
    Stanford California 94305 United States
  • University of Alabama at Birmingham accepting new patients
    Birmingham Alabama 35294-3300 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT06153251
Phase
Phase 1 Multiple Myeloma Research Study
Study Type
Interventional
Participants
Expecting 130 study participants
Last Updated