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

Recruiting now · Phase 1

Conditions studied: Multiple Myeloma

In brief

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).

Key facts

Study ID

NCT06121843

Run by

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

People needed

187

Starts

2024-02-22

Expected to finish

2028-08-01

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of relapsed and/or refractory multiple myeloma (RRMM) treated with at least 3 (Part 1), history of RRMM or at least 1 but not greater than 3 prior anti-myeloma treatment (PAMT) regimens (Part 2, Arms A, B, C, and D); history of quadruple class exposed RRMM having received BCMA TCE as the most recent line of therapy (Part 2, Arm E).
• Measurable multiple myeloma (MM) as per International Myeloma Working Group (IMWG).
• Eastern Cooperative Oncology Group performance status of 0-1.
• Adherence to contraception requirements.

You may not qualify if…

• Prior treatment with alnuctamab (Arm A), mezigdomide (Arms B and E), iberdomide (Arm C), elranatamab (Arm D) or BCMA-targeting therapy (Part 2 Arms A and D).
• Prior treatment with GPRC5D-targeting therapies as of Protocol Amendment 02 (Part 1 and Part 2).
• Other protocol-defined inclusion/exclusion criteria apply.

Where it is running

• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
• Mayo Clinic in Arizona - Phoenix — Phoenix, Arizona, United States (enrolling)
• City of Hope Comprehensive Cancer Center — Duarte, California, United States (enrolling)
• Mayo Clinic in Florida — Jacksonville, Florida, United States (enrolling)
• Northside Hospital — Atlanta, Georgia, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Mayo Clinic in Rochester, Minnesota — Rochester, Minnesota, United States (enrolling)
• University Of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
• Roswell Park Cancer Institute — Buffalo, New York, United States (enrolling)
• Laura and Isaac Perlmutter Cancer Center — New York, New York, United States (enrolling)
• Arthur J.E. Child Comprehensive Cancer Centre — Calgary, Alberta, Canada (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Tennessee Oncology — Nashville, Tennessee, United States (enrolling)
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Local Institution - 0009 — New York, New York, United States
• Local Institution - 0023 — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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