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Multiple MyelomaPhase 2QUINTESSENTIALNCT06297226

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

A Phase 2 study testing Arlocabtagene Autoleucel in people with Multiple Myeloma, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 52 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Arlocabtagene Autoleucel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
52 sitesin 4 countries
Study dates
21 Mar 2024to 30 Jun 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

52 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

52 sites in 4 countries

United States41 sites, 38 recruiting

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

    Nisha Joseph, Site 0009, 502-608-5503

    Recruiting

  • Northside Hospital

    Atlanta, Georgia, 30342

    Scott Solomon, Site 0004, 404-255-1930

    Recruiting

  • Local Institution - 0069

    Austin, Texas, 78704

    Withdrawn

  • Local Institution - 0065

    Baltimore, Maryland, 21218

    Withdrawn

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-3300

    Susan Bal, Site 0001, 205-934-1908

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Diana Cirstea, Site 0039, 617-724-4000

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Omar Nadeem, Site 0036, 617-632-3000

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Ehsan Malek, Site 0046, 216-286-4441

    Recruiting

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina, 27599-7305

    Eben Lichtman, Site 0031, 617-842-6051

    Recruiting

  • Local Institution - 0067

    Charlotte, North Carolina, 28204

    Withdrawn

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

    Seema Singhal, Site 0005, 312-505-1290

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Jennifer Cooperrider, Site 0056

    Recruiting

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

    Kruti Patel, Site 0054, 888-961-4156

    Recruiting

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Srinivas Devarakonda, Site 0032, 570-423-0522

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Larry Anderson, Site 0035, 214-648-5906

    Recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

    Tara Gregory, Site 0049, 720-754-4800

    Recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

    Ambuga Badari, Site 0025

    Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Krina Patel, Site 0027, 713-792-6662

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Christopher Strouse, Site 0019, 630-917-8956

    Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

    Sikander Ailawadhi, Site 0062, 904-953-0853

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Sharmilan Thanendrarajan, Site 0037, 000-000-0000

    Recruiting

  • UCLA Hematology/Oncology - Westwood (Building 200 Suite 214)

    Los Angeles, California, 90095

    Sarah Larson, Site 0028, 310-829-5471

    Recruiting

  • Norton Women's and Children's Hospital

    Louisville, Kentucky, 40207

    Don Stevens, Site 0026, 502-899-3366

    Recruiting

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

    Zhubin Gahvari, Site 0015, 608-262-9317

    Recruiting

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida, 33176

    George Nahas, Site 0045, 201-310-8558

    Recruiting

  • Tennessee Oncology

    Nashville, Tennessee, 37203

    Jesus Berdeja, Site 0066, 615-329-0570

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Eden Biltibo, Site 0043

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

    Mansi Shah, Site 0034, 732-209-5479

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Adriana Rossi, Site 0002, 646-962-6500

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Sham Mailankody, Site 0003, 646-608-3712

    Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

    gary Simmons, Site 0068, 757-461-7084

    Recruiting

  • Sidney Kimmel Cancer Center - Jefferson Health

    Philadelphia, Pennsylvania, 19107

    Usama Gergis, Site 0070, 917-698-4310

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Amrita Desai, Site 0038, 503-494-0896

    Recruiting

  • Mayo Clinic in Rochester, Minnesota

    Rochester, Minnesota, 55905

    Taxiarchis Kourelis, Site 0033, 855-776-0015

    Recruiting

  • LDS Hospital

    Salt Lake City, Utah, 84143

    Bradley Hunter, Site 0050, 801-408-3729

    Recruiting

  • Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute

    San Antonio, Texas, 78229

    Paul Shaughnessy, Site 0055, 210-670-2313

    Recruiting

  • UCSF Helen Diller Medical Center at Parnassus Heights

    San Francisco, California, 94143

    Anupama Kumar, Site 0018, 415-514-0768

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Rahul Banerjee, Site 0011, 206-606-1453

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Michael Slade, Site 0010, 314-454-8304

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Ciara Freeman, Site 0029, 813-745-2475

    Recruiting

  • The University of Kansas Cancer Center - Westwood

    Westwood, Kansas, 66205

    Al-Ola Abdallah, Site 0016, 918-261-6196

    Recruiting

Other trials in United States

Japan5 sites, 5 recruiting

  • Chiba University Hospital

    Chiba, 260-8677

    Emiko Sakaida, Site 0061, 0061

    Recruiting

  • University Hospital,Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

    Junya Kuroda, Site 0059, 0059

    Recruiting

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

    Shinsuke Iida, Site 0057, 0057

    Recruiting

  • Hyogo Medical University Hospital

    Nishinomiya, Hyōgo, 663-8501

    Satoshi Yoshihara, Site 0058, 0058

    Recruiting

  • Japanese Red Cross Medical Center

    Shibuya-ku, Tokyo, 150-8935

    Tadao Ishida, Site 0060, 0060

    Recruiting

Other trials in Japan

Australia4 sites, 4 recruiting

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4029

    Nicholas Weber, Site 0075, +61736460818

    Recruiting

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

    Joy Ho, Site 0077, +61295158031

    Recruiting

  • The Alfred Hospital

    Melbourne, Victoria, 3004

    Sueh-Li Lim, Site 0074, 0403374221

    Recruiting

  • St Vincent's Hospital

    Melbourne, Victoria, 3065

    Hang Quach, Site 0076, +61392313189

    Recruiting

Other trials in Australia

Canada2 sites, 2 recruiting

  • Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

    Nizar Bahlis, Site 0020, 4032202801

    Recruiting

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

    Michael Sebag, Site 0021, 514-934-1934-31558

    Recruiting

Other trials in Canada

About this study

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)

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.

Being tested
Arlocabtagene Autoleucel
Keywords
Relapsed or Refractory Multiple Myeloma, Multiple Myeloma, BMS-986393, CAR T Cell Therapy, RRMM, Arlocabtagene Autoleucel
Medical subject headings
Multiple Myeloma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arlocabtagene AutoleucelBiological

    Also called CC-95266,, GPRC5D CAR T cells, BMS-986393, Arlo-cel

    Specified dose on specified days

Study groups in NCT06297226
Study groupRoleWhat they receive
Arlocabtagene Autoleucel Cohort 1ExperimentalNot described
Receives: Biological: Arlocabtagene Autoleucel
Arlocabtagene Autoleucel Cohort 2ExperimentalNot described
Receives: Biological: Arlocabtagene Autoleucel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Up to approximately 5 years

Secondary outcomes (17)

  1. BOR of partial response (PR) or better

    The number and percent of participants achieving BOR of PR in quadruple class exposed participants received at least 3 prior LOT

    Measured: Up to approximately 5 years

  2. Best overall response (BOR) of complete response (CR) including stringent complete response (sCR)

    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)

    Measured: Up to approximately 5 years

  3. Minimal residual disease (MRD) negative status

    Measured: Up to approximately 5 years

  4. 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)

    Measured: Up to approximately 5 years

  5. Duration of response (DOR) assessed by an IRC

    Median DOR for responders only as estimated using Kaplan-Meier method and frequencies of participants who progressed, died, and were censored

    Measured: Up to approximately 5 years

  6. Progression-free survival (PFS)

    Measured: Up to approximately 5 years

  7. Overall survival (OS)

    Measured: Up to approximately 5 years

  8. Overall response rate (ORR) assessed by an Investigator

    Measured: Up to approximately 5 years

  9. Complete response rate (CRR) assessed by an Investigator

    Measured: Up to approximately 5 years

  10. Time to response (TTR) assessed by an Investigator

    Measured: Up to approximately 5 years

  11. Duration of response (DOR) assessed by an Investigator

    Measured: Up to approximately 5 years

  12. Progression-free survival (PFS) with BOR according to the IMWG Response Criteria assessed by Investigator

    Measured: Up to approximately 5 years

  13. Maximum observed plasma concentration (Cmax)

    Measured: Up to approximately 5 years

  14. Area under the concentration-time curve (AUC)

    Measured: Up to approximately 5 years

  15. Time of maximum observed plasma concentration (Tmax)

    Measured: Up to approximately 5 years

  16. Mean changes from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) selected subscales

    Measured: Up to approximately 5 years

  17. Incidence of healthcare resource utilization (HCRU) events during treatment and during post-treatment follow-up

    Measured: Up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2024
  2. Study start21 Mar 2024
  3. Primary completion31 Jul 2026
  4. Study completion30 Jun 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06297226
Sponsor's protocol ID
CA088-1000
Acronym
QUINTESSENTIAL
Status last verified
Oct 2026
First submitted
28 Feb 2024
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Arlocabtagene Autoleucel in people with Multiple Myeloma, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 52 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Japan, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1: Best overall response (BOR) of partial response (PR) or better (time frame: Up to approximately 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06297226.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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