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

May 26, 2026 updated by: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

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)

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

230

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Royal Prince Alfred Hospital
        • Contact:
          • Joy Ho, Site 0077
          • Phone Number: +61295158031
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Recruiting
        • Royal Brisbane and Women'S Hospital
        • Contact:
          • Nicholas Weber, Site 0075
          • Phone Number: +61736460818
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
        • Contact:
          • Sueh-Li Lim, Site 0074
          • Phone Number: 0403374221
      • Melbourne, Victoria, Australia, 3065
        • Recruiting
        • St Vincent's Hospital
        • Contact:
          • Hang Quach, Site 0076
          • Phone Number: 61392882698
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Recruiting
        • Arthur J.E. Child Comprehensive Cancer Centre
        • Contact:
          • Nizar Bahlis, Site 0020
          • Phone Number: 4032202801
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre
        • Contact:
          • Michael Sebag, Site 0021
          • Phone Number: 514-934-1934-31558
  • Japan
      • Chiba, Japan, 260-8677
        • Recruiting
        • Chiba University Hospital
        • Contact:
          • Emiko Sakaida, Site 0061
          • Phone Number: +81432227171
      • Kyoto, Japan, 602-8566
        • Recruiting
        • University Hospital,Kyoto Prefectural University of Medicine
        • Contact:
          • Junya Kuroda, Site 0059
          • Phone Number: 81752515740
      • Tokyo, Japan, 150-8935
        • Recruiting
        • Japanese Red Cross Medical Center
        • Contact:
          • Tadao Ishida, Site 0060
          • Phone Number: 8133400104
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Recruiting
        • Nagoya City University Hospital
        • Contact:
          • Shinsuke Iida, Site 0057
          • Phone Number: 81528515511
    • Hyōgo
      • Nishinomiya, Hyōgo, Japan, 663-8501
        • Recruiting
        • Hyogo Medical University Hospital
        • Contact:
          • Satoshi Yoshihara, Site 0058
          • Phone Number: +81-90-2102-4734
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
          • Susan Bal, Site 0001
          • Phone Number: 205-934-1908
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Recruiting
        • Banner MD Anderson Cancer Center
        • Contact:
          • Ambuga Badari, Site 0025
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas for Medical Sciences
        • Contact:
          • Sharmilan Thanendrarajan, Site 0037
          • Phone Number: 000-000-0000
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Hematology/Oncology - Westwood (Building 200 Suite 214)
        • Contact:
          • Sarah Larson, Site 0028
          • Phone Number: 310-829-5471
      • San Francisco, California, United States, 94143
        • Recruiting
        • UCSF Helen Diller Medical Center at Parnassus Heights
        • Contact:
          • Anupama Kumar, Site 0018
          • Phone Number: 415-514-0768
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Colorado Blood Cancer Institute
        • Contact:
          • Tara Gregory, Site 0049
          • Phone Number: 720-754-4800
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic in Florida
        • Contact:
          • Vivek Roy, Site 0062
          • Phone Number: 000-000-0000
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Cancer Institute at Baptist Health, Inc.
        • Contact:
          • George Nahas, Site 0045
          • Phone Number: 201-310-8558
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
          • Ciara Freeman, Site 0029
          • Phone Number: 813-745-2475
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Northside Hospital
        • Contact:
          • Scott Solomon, Site 0004
          • Phone Number: 404-255-1930
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute of Emory University
        • Contact:
          • Nisha Joseph, Site 0009
          • Phone Number: 502-608-5503
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center
        • Contact:
          • Jennifer Cooperrider, Site 0056
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital
        • Contact:
          • Seema Singhal, Site 0005
          • Phone Number: 312-505-1290
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Contact:
          • Christopher Strouse, Site 0019
          • Phone Number: 630-917-8956
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • The University of Kansas Cancer Center - Westwood
        • Contact:
          • Leyla Shune, Site 0016
          • Phone Number: 913-588-6029
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Norton Women's and Children's Hospital
        • Contact:
          • Don Stevens, Site 0026
          • Phone Number: 502-899-3366
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Withdrawn
        • Local Institution - 0065
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
          • Diana Cirstea, Site 0039
          • Phone Number: 617-724-4000
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Contact:
          • Omar Nadeem, Site 0036
          • Phone Number: 617-632-3000
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester, Minnesota
        • Contact:
          • Taxiarchis Kourelis, Site 0033
          • Phone Number: 855-776-0015
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
          • Michael Slade, Site 0010
          • Phone Number: 314-454-8304
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
          • Mansi Shah, Site 0034
          • Phone Number: 732-209-5479
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Contact:
          • Ehsan Malek, Site 0046
          • Phone Number: 216-286-4441
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Sham Mailankody, Site 0003
          • Phone Number: 646-608-3712
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
          • Adriana Rossi, Site 0002
          • Phone Number: 646-962-6500
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7305
        • Recruiting
        • University of North Carolina Medical Center
        • Contact:
          • Eben Lichtman, Site 0031
          • Phone Number: 617-842-6051
      • Charlotte, North Carolina, United States, 28204
        • Withdrawn
        • Local Institution - 0067
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Oncology Hematology Care
        • Contact:
          • Kruti Patel, Site 0054
          • Phone Number: 888-961-4156
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
        • Contact:
          • Srinivas Devarakonda, Site 0032
          • Phone Number: 570-423-0522
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
          • Amrita Desai, Site 0038
          • Phone Number: 503-494-0896
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Sidney Kimmel Cancer Center - Jefferson Health
        • Contact:
          • Usama Gergis, Site 0070
          • Phone Number: 917-698-4310
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • Muhamed Baljevic, Site 0043
          • Phone Number: 917-913-9166
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology
        • Contact:
          • Jesus Berdeja, Site 0066
          • Phone Number: 615-329-0570
    • Texas
      • Austin, Texas, United States, 78704
        • Withdrawn
        • Local Institution - 0069
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
        • Contact:
          • Larry Anderson, Site 0035
          • Phone Number: 214-648-5906
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Contact:
          • Krina Patel, Site 0027
          • Phone Number: 713-792-6662
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute
        • Contact:
          • Paul Shaughnessy, Site 0055
          • Phone Number: 210-670-2313
    • Utah
      • Salt Lake City, Utah, United States, 84143
        • Recruiting
        • LDS Hospital
        • Contact:
          • Bradley Hunter, Site 0050
          • Phone Number: 801-408-3729
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Oncology Associates
        • Contact:
          • gary Simmons, Site 0068
          • Phone Number: 757-461-7084
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center
        • Contact:
          • Rahul Banerjee, Site 0011
          • Phone Number: 206-606-1453
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Carbone Cancer Center - University Hospital
        • Contact:
          • Zhubin Gahvari, Site 0015
          • Phone Number: 608-262-9317

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arlocabtagene Autoleucel Cohort 1
Biological: Arlocabtagene Autoleucel
Specified dose on specified days
Other Names:
  • CC-95266,
  • GPRC5D CAR T cells
  • Arlo-cel
  • BMS-986393
Experimental: Arlocabtagene Autoleucel Cohort 2
Biological: Arlocabtagene Autoleucel
Specified dose on specified days
Other Names:
  • CC-95266,
  • GPRC5D CAR T cells
  • Arlo-cel
  • BMS-986393

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort 1: Best overall response (BOR) of partial response (PR) or better
Time Frame: 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)
Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
BOR of partial response (PR) or better
Time Frame: 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
Up to approximately 5 years
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)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Progression-free survival (PFS)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Overall response rate (ORR) assessed by an Investigator
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Complete response rate (CRR) assessed by an Investigator
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Time to response (TTR) assessed by an Investigator
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Duration of response (DOR) assessed by an Investigator
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Progression-free survival (PFS) with BOR according to the IMWG Response Criteria assessed by Investigator
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Maximum observed plasma concentration (Cmax)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Area under the concentration-time curve (AUC)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Time of maximum observed plasma concentration (Tmax)
Time Frame: Up to approximately 5 years
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
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Incidence of healthcare resource utilization (HCRU) events during treatment and during post-treatment follow-up
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Minimal residual disease (MRD) negative status
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Best overall response (BOR) of complete response (CR) including stringent complete response (sCR)
Time Frame: 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)
Up to approximately 5 years
Duration of response (DOR) assessed by an IRC
Time Frame: Up to approximately 5 years
Median DOR for responders only as estimated using Kaplan-Meier method and frequencies of participants who progressed, died, and were censored
Up to approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2032

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA088-1000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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