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

Phase 2

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Biological: Arlocabtagene Autoleucel (BMS-986393)

• Registration Number: NCT06297226
• Lead Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-03-07
• Study Start: 2024-03-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-20
• Primary Completion: 2027-06-30
• Study Completion: 2032-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arlocabtagene Autoleucel (BMS-986393)	Arlocabtagene Autoleucel (BMS-986393)	-

Primary Outcome Measures

Name	Time	Method
Best overall response (BOR) of partial response (PR) or better	Up to approximately 5 years	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)

Secondary Outcome Measures

Name	Time	Method
Duration of response (DOR) assessed by an Investigator	Up to approximately 5 years
Complete response rate (CRR) assessed by an Investigator	Up to approximately 5 years
Time to response (TTR) assessed by an Investigator	Up to approximately 5 years
Best overall response (BOR) of complete response (CR) including stringent complete response (sCR)	Up to approximately 5 years	The number and percent of participants achieving complete response (CR) \[including stringent complete response sCR\] in participants having received at least 3 prior lines of therapy (LOT)
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)	Up to approximately 5 years
Progression-free survival (PFS)	Up to approximately 5 years
BOR of partial response (PR) or better	Up to approximately 5 years	The number and percent of participants achieving BOR of PR in quadruple class exposed participants received at least 3 prior LOT
Minimal residual disease (MRD) negative status	Up to approximately 5 years
Duration of response (DOR) assessed by an IRC	Up to approximately 5 years
Overall survival (OS)	Up to approximately 5 years
Overall response rate (ORR) assessed by an Investigator	Up to approximately 5 years
Progression-free survival (PFS) with BOR according to the IMWG Response Criteria assessed by Investigator	Up to approximately 5 years
Maximum observed plasma concentration (Cmax)	Up to approximately 5 years
Area under the concentration-time curve (AUC)	Up to approximately 5 years
Time of maximum observed plasma concentration (Tmax)	Up to approximately 5 years
Mean changes from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) selected subscales	Up to approximately 5 years
Mean changes from baseline in European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) selected subscales	Up to approximately 5 years
Incidence of healthcare resource utilization (HCRU) events during treatment and during post-treatment follow-up	Up to approximately 5 years

Trial Locations

Locations (52)

Tennessee Oncology; 🇺🇸 Nashville, Tennessee, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Banner MD Anderson Cancer Center; 🇺🇸 Gilbert, Arizona, United States

Colorado Blood Cancer Institute; 🇺🇸 Denver, Colorado, United States

Local Institution - 0062; 🇺🇸 Jacksonville, Florida, United States

Miami Cancer Institute at Baptist Health, Inc.; 🇺🇸 Miami, Florida, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Winship Cancer Institute of Emory University; 🇺🇸 Atlanta, Georgia, United States

Northside Hospital; 🇺🇸 Atlanta, Georgia, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

The University of Kansas Cancer Center - Westwood; 🇺🇸 Westwood, Kansas, United States

Norton Women's and Children's Hospital; 🇺🇸 Louisville, Kentucky, United States

Local Institution - 0065; 🇺🇸 Baltimore, Maryland, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Local Institution - 0033; 🇺🇸 Rochester, Minnesota, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

UCSF Helen Diller Medical Center at Parnassus Heights; 🇺🇸 San Francisco, California, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

UCLA Hematology/Oncology - Westwood (Building 200 Suite 214); 🇺🇸 Los Angeles, California, United States

LDS Hospital; 🇺🇸 Salt Lake City, Utah, United States

Fred Hutchinson Cancer Center; 🇺🇸 Seattle, Washington, United States

University Hospital and UW Health Clinics; 🇺🇸 Madison, Wisconsin, United States

Local Institution - 0077; 🇦🇺 Camperdown, New South Wales, Australia

Local Institution - 0075; 🇦🇺 Brisbane, Queensland, Australia

Local Institution - 0074; 🇦🇺 Melbourne, Victoria, Australia

Local Institution - 0076; 🇦🇺 Melbourne, Victoria, Australia

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

University of North Carolina Medical Center; 🇺🇸 Chapel Hill, North Carolina, United States

Local Institution - 0067; 🇺🇸 Charlotte, North Carolina, United States

Oncology Hematology Care; 🇺🇸 Cincinnati, Ohio, United States

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Local Institution - 0070; 🇺🇸 Philadelphia, Pennsylvania, United States

Local Institution - 0043; 🇺🇸 Nashville, Tennessee, United States

Local Institution - 0069; 🇺🇸 Austin, Texas, United States

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute; 🇺🇸 San Antonio, Texas, United States

Virginia Oncology Associates; 🇺🇸 Norfolk, Virginia, United States

Tom Baker Cancer Center; 🇨🇦 Calgary, Alberta, Canada

McGill University Health Centre; 🇨🇦 Montréal, Quebec, Canada

Local Institution - 0057; 🇯🇵 Nagoya, Aichi, Japan

Local Institution - 0058; 🇯🇵 Nishinomiya, Hyogo, Japan

Local Institution - 0061; 🇯🇵 Chiba, Japan

Local Institution - 0059; 🇯🇵 Kyoto, Japan

Local Institution - 0060; 🇯🇵 Tokyo, Japan