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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company

About this trial

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.

Eligibility criteria

Qualifiers

Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria.

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).

Documented disease progression during or after their last anti-myeloma regimen as per IMWG 2016 criteria.

Participants must have measurable disease during screening.

Disqualifiers

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. Participants with severe infection, severe sepsis or bacteremia in the last 28 days prior to leukapheresis are excluded.

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.

Trial design

Treatments tested in this trial

  • Arlocabtagene Autoleucel

Treatment groups

230 Participants
are divided into 2 treatment groups