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

February 23, 2024 updated by: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain the NCT# and Site#

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75010
        • Not yet recruiting
        • Local Institution - 0019
        • Contact:
          • Site 0019
  • Germany
      • Köln, Germany, 50937
        • Not yet recruiting
        • Local Institution - 0017
        • Contact:
          • Site 0017
      • Wuerzburg, Germany, 97080
        • Not yet recruiting
        • Local Institution - 0018
        • Contact:
          • Site 0018
  • Spain
      • Salamanca, Spain, 37007
        • Not yet recruiting
        • Local Institution - 0014
        • Contact:
          • Site 0014
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Not yet recruiting
        • Local Institution - 0015
        • Contact:
          • Site 0015
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
          • Luciano Costa, Site 0001
          • Phone Number: 205-934-9695
    • California
      • Duarte, California, United States, 91010
        • Not yet recruiting
        • Local Institution - 0003
        • Contact:
          • Site 0003
      • San Francisco, California, United States, 94143
        • Not yet recruiting
        • Local Institution - 0011
        • Contact:
          • Site 0011
      • Stanford, California, United States, 94305
        • Not yet recruiting
        • Local Institution - 0006
        • Contact:
          • Site 0006
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Colorado Blood Cancer Institute
        • Contact:
          • Tara Gregory, Site 0013
          • Phone Number: 720-754-4800
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Not yet recruiting
        • Local Institution - 0005
        • Contact:
          • Site 0005
    • Florida
      • Tampa, Florida, United States, 33612
        • Not yet recruiting
        • Local Institution - 0016
        • Contact:
          • Site 0016
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Sham Mailankody, Site 0004
          • Phone Number: 646-608-3712
      • New York, New York, United States, 10029
        • Not yet recruiting
        • Local Institution - 0010
        • Contact:
          • Site 0010
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Not yet recruiting
        • Local Institution - 0008
        • Contact:
          • Site 0008
      • Nashville, Tennessee, United States, 37203
        • Not yet recruiting
        • Local Institution - 0020
        • Contact:
          • Site 0020
    • Washington
      • Seattle, Washington, United States, 98104
        • Not yet recruiting
        • Local Institution - 0012
        • Contact:
          • Site 0012

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Administration of BMS-986453
Drug: Cyclophosphamide
Specified dose on specified days
Drug: Fludarabine
Specified dose on specified days
Drug: BMS-986453
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 2 years
Up to 2 years
Number of participants with AEs leading to discontinuation
Time Frame: Up to 2 years
Up to 2 years
Number of participants with treatment-emergent adverse events (AEs)
Time Frame: Up to 2 years
Up to 2 years
Number of participants with AEs leading to death
Time Frame: Up to 2 years
Up to 2 years
Number of participants with dose-limiting toxicities (DLTs)
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to 2 years
Up to 2 years
Progression-free survival (PFS)
Time Frame: Up to 2 years
Up to 2 years
Overall response rate (ORR)
Time Frame: Up to 2 years
Up to 2 years
Duration of response (DOR)
Time Frame: Up to 2 years
Up to 2 years
Time to response (TTR)
Time Frame: Up to 2 years
Up to 2 years
Complete response rate (CRR)
Time Frame: Up to 2 years
Up to 2 years
Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))
Time Frame: Up to 2 years
Up to 2 years
Maximum observed concentration (Cmax)
Time Frame: Up to 2 years
Up to 2 years
Time of maximum observed concentration (Tmax)
Time Frame: Up to 2 years
Up to 2 years
Number of participants with very good partial response (VGPR) or better
Time Frame: Up to 2 years
Up to 2 years
Time to complete response (TTCR)
Time Frame: Up to 2 years
Up to 2 years
Duration of complete response (DOCR)
Time Frame: Up to 2 years
Up to 2 years
Persistence of BMS-986453 in peripheral blood
Time Frame: Up to 2 years
Defined as a transgene count greater than or equal to the lower limit of detection (LLOD)
Up to 2 years
Expansion rate
Time Frame: Up to 2 years
Defined as Cmax divided by Tmax
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2024

Primary Completion (Estimated)

November 29, 2027

Study Completion (Estimated)

November 29, 2027

Study Registration Dates

First Submitted

November 22, 2023

First Submitted That Met QC Criteria

November 22, 2023

First Posted (Actual)

December 1, 2023

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA119-0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-andresearch/disclosure-commitment.html

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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