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

Phase 2RecruitingNCT06297226

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company230 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

230

Conditions

Multiple Myeloma

Interventions

Arlocabtagene AutoleucelBIOLOGICAL

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria * 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. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria * 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.

Locations (52)

Outcomes

Primary Outcomes

Cohort 1: Best overall response (BOR) of partial response (PR) or better

The number and percent of participants achieving BOR of partial response (PR) or better in quadruple class exposed participants received at least 4 prior lines of therapy (LOT)