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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
View on ClinicalTrials.gov →
NCT06121843
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
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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
View on ClinicalTrials.gov →
NCT06121843