Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma
Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma
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.
Multiple Myeloma
Phase II
Adults
Mol. targeted/Immunotherapy/Biologics
BMS-986393
Baljevic, Muhamed
International
Vanderbilt University
08-11-2025
Eligibility
18 Years and older
ALL
false
Inclusion Criteria:
Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria.
Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria.
Received at least 3 classes of MM treatment \[including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, and at least 3 prior lines of therapy (LOT).
Received at least 3 classes of MM treatment \[including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, and at least 3 prior lines of therapy (LOT).
Documented disease progression during or after their last anti-myeloma regimen as per IMWG 2016 criteria.
Documented disease progression during or after their last anti-myeloma regimen as per IMWG 2016 criteria.
Participants must have measurable disease during screening.
Participants must have measurable disease during screening.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria:
Active or history of central nervous system involvement with MM.
Active or history of central nervous system involvement with MM.
Active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis.
Active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis.
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.
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.
Other protocol-defined Inclusion/Exclusion criteria apply.
Other protocol-defined Inclusion/Exclusion criteria apply.
Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria.
Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria.
Received at least 3 classes of MM treatment \[including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, and at least 3 prior lines of therapy (LOT).
Received at least 3 classes of MM treatment \[including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, and at least 3 prior lines of therapy (LOT).
Documented disease progression during or after their last anti-myeloma regimen as per IMWG 2016 criteria.
Documented disease progression during or after their last anti-myeloma regimen as per IMWG 2016 criteria.
Participants must have measurable disease during screening.
Participants must have measurable disease during screening.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria:
Active or history of central nervous system involvement with MM.
Active or history of central nervous system involvement with MM.
Active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis.
Active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis.
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.
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.
Other protocol-defined Inclusion/Exclusion criteria apply.
Other protocol-defined Inclusion/Exclusion criteria apply.
