RecruitingPhase 1NCT06121843

A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma

A Phase 1, Multicenter, Open-label Study to Evaluate the Safety and Preliminary Efficacy of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma and Determine the Recommended Dose for Each Add-on Investigational Component


Sponsor

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

Enrollment

147 participants

Start Date

Feb 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to establish a safe and tolerable dose of arlocabtagene autoleucel (BMS-986393) in combinations with alnuctamab, mezigdomide, iberdomide, and elranatamab in participants with relapsed and/or refractory multiple myeloma (RRMM).


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • History of relapsed and/or refractory multiple myeloma (RRMM) treated with at least 3 (Part 1) or at least 1 but not greater than 3 prior anti-myeloma treatment regimens (Part 2).
  • Measurable multiple myeloma (MM) as per International Myeloma Working Group (IMWG).
  • Eastern Cooperative Oncology Group performance status of 0-1.

Exclusion Criteria2

  • Prior treatment with alnuctamab (Arm A), mezigdomide (Arm B), iberdomide (Arm C), elranatamab (Arm D) or BCMA-targeting therapy (Part 2 Arms A and D).
  • Prior treatment with GPRC5D-targeting therapies.

Interventions

DRUGBMS-986393

Specified dose on specified days

DRUGAlnuctamab

Specified dose on specified days

DRUGMezigdomide

Specified dose on specified days

DRUGIberdomide

Specified dose on specified days

DRUGElranatamab

Specified dose on specified days


Locations(19)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Mayo Clinic in Arizona - Phoenix

Phoenix, Arizona, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Northside Hospital

Atlanta, Georgia, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, United States

University Of Nebraska Medical Center

Omaha, Nebraska, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Laura and Isaac Perlmutter Cancer Center

New York, New York, United States

Local Institution - 0009

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Local Institution - 0023

Pittsburgh, Pennsylvania, United States

Tennessee Oncology

Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT06121843


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