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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

RECRUITINGPhase 1Sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Actively Recruiting
PhasePhase 1
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company
Started2024-02-22
Est. completion2028-08-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations17 sites

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

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Conditions2

CancerMultiple Myeloma

Interventions6

Locations17 sites

University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
Susan Bal, Site 0008205-934-1908
Mayo Clinic in Arizona - Phoenix
Julia Wiedmeier-Nutor, Site 0002855-776-0015
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Myo Htut, Site 0028626-256-4673
Mayo Clinic in Florida
Sikander Ailawadhi, Site 0005904-953-0853
Northside Hospital
Scott Solomon, Site 0006404-255-1930

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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