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Trial ID CA088-1000  |   NCT06297226

Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma

Summary

  • Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • 44
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The purpose of this study is to evaluate the effectiveness and safety of Arlocabtagene Autoleucel (BMS-986393) in participants with relapsed or refractory multiple myeloma.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria.
    1. Received at least 4 classes of MM treatment [including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, anti-BCMA therapy, and at least 3 prior lines of therapy (LOT).
      1. Documented disease progression during or after their last anti-myeloma regimen as per IMWG 2016 criteria.
        1. Participants must have measurable disease during screening.
          1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

            Exclusion Criteria

            Exclusion Criteria Icon
            • Active or history of central nervous system involvement with MM.
              1. Active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis. Participants with severe infection, severe sepsis or bacteremia in the last 28 days prior to leukapheresis are excluded.
                1. Received any prior therapy directed at G protein-coupled receptor class C, group 5, member D (GPRC5D) or has received other prior treatment for MM without the required washout prior to leukapheresis.
                  Additional Information *
                  • Other protocol-defined Inclusion/Exclusion criteria apply.

                    Treatment Options

                    Study Arms

                    ASSIGNED INTERVENTION

                    Study Arms

                    Experimental: Arlocabtagene Autoleucel Cohort 1

                    ASSIGNED INTERVENTION
                    • Biological: Arlocabtagene Autoleucel

                    Study Arms

                    Experimental: Arlocabtagene Autoleucel Cohort 2

                    ASSIGNED INTERVENTION
                    • Biological: Arlocabtagene Autoleucel
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