Clinical trial NCT06297226: Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma
Official title: A Phase 2, Open-Label, Multicenter Study of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma (QUINTESSENTIAL)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Relapsed or Refractory Multiple Myeloma
Multiple Myeloma
BMS-986393
CAR T Cell Therapy
RRMM
Arlocabtagene Autoleucel
Lead sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Sponsor class: INDUSTRY
First posted: 2024-03-07
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: Inclusion 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).
* 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.
* 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.

Primary outcomes:
measure: Best overall response (BOR) of partial response (PR) or better
timeFrame: Up to approximately 5 years
Secondary outcomes:
measure: Best overall response (BOR) of complete response (CR) including stringent complete response (sCR)
timeFrame: Up to approximately 5 years
measure: BOR of partial response (PR) or better
timeFrame: Up to approximately 5 years
measure: Minimal residual disease (MRD) negative status
timeFrame: Up to approximately 5 years
measure: Time from BMS-986393 infusion to first documentation of response of partial response (PR) or better according to the International Myeloma Working Group (IMWG) Response Criteria assessed by an independent review committee (IRC)
timeFrame: Up to approximately 5 years
measure: Duration of response (DOR) assessed by an IRC
timeFrame: Up to approximately 5 years
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 5 years
measure: Overall survival (OS)
timeFrame: Up to approximately 5 years
measure: Overall response rate (ORR) assessed by an Investigator
timeFrame: Up to approximately 5 years
measure: Complete response rate (CRR) assessed by an Investigator
timeFrame: Up to approximately 5 years
measure: Time to response (TTR) assessed by an Investigator
timeFrame: Up to approximately 5 years
measure: Duration of response (DOR) assessed by an Investigator
timeFrame: Up to approximately 5 years
measure: Progression-free survival (PFS) with BOR according to the IMWG Response Criteria assessed by Investigator
timeFrame: Up to approximately 5 years
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to approximately 5 years
measure: Area under the concentration-time curve (AUC)
timeFrame: Up to approximately 5 years
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to approximately 5 years
measure: Mean changes from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) selected subscales
timeFrame: Up to approximately 5 years
measure: Mean changes from baseline in European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) selected subscales
timeFrame: Up to approximately 5 years
measure: Incidence of healthcare resource utilization (HCRU) events during treatment and during post-treatment follow-up
timeFrame: Up to approximately 5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 214)
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Medical Center at Parnassus Heights
state: California
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Jacksonville
country: United States
facility: Local Institution - 0062
state: Florida
city: Miami
country: United States
facility: Miami Cancer Institute at Baptist Health, Inc.
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Westwood
country: United States
facility: The University of Kansas Cancer Center - Westwood
state: Kansas
city: Louisville
country: United States
facility: Norton Women's and Children's Hospital
state: Kentucky
city: Baltimore
country: United States
facility: Local Institution - 0065
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic in Rochester, Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Local Institution - 0067
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Columbus
country: United States
facility: The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Local Institution - 0070
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 0043
state: Tennessee
city: Austin
country: United States
facility: Local Institution - 0069
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute
state: Texas
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Madison
country: United States
facility: University Hospital and UW Health Clinics
state: Wisconsin
city: Camperdown
country: Australia
facility: Local Institution - 0077
state: New South Wales
city: Brisbane
country: Australia
facility: Local Institution - 0075
state: Queensland
city: Melbourne
country: Australia
facility: Local Institution - 0074
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution - 0076
state: Victoria
city: Calgary
country: Canada
facility: Tom Baker Cancer Center
state: Alberta
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Nishinomiya
country: Japan
facility: Hyogo Medical University Hospital
state: Hyogo
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Kyoto
country: Japan
facility: Local Institution - 0059
city: Tokyo
country: Japan
facility: Japanese Red Cross Medical Center
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: