ClinicalTrials.gg
RecruitingNCT06297226QUINTESSENTIALUpdated Oct 6, 2026

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 interventional study of Arlocabtagene Autoleucel in Multiple Myeloma, sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company. Recruiting at 52 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company (part of Bristol-Myers Squibb) · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 7 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
230
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Multiple Myeloma

Keywords

  • Relapsed or Refractory Multiple Myeloma
  • Multiple Myeloma
  • BMS-986393
  • CAR T Cell Therapy
  • RRMM
  • Arlocabtagene Autoleucel
03

In context

Multiple Myeloma

3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.

This study's planned enrollment of 230 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company is the lead sponsor of 17 studies on the registry; 12 are open to participants now.

First submitted after Juno Therapeutics, Inc. became part of Bristol-Myers Squibb.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (LOT).
  • Documented disease progression during or after their last anti-myeloma regimen as per IMWG 2016 criteria.
  • Participants must have during screening.
  • (ECOG) performance status of 0 or 1.

Exclusion criteria

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 prior to leukapheresis.
  • Other protocol-defined Inclusion/Exclusion criteria apply.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
230 participants (estimated)

Study arms

  • Experimental
    Arlocabtagene Autoleucel Cohort 1

    Biological: Arlocabtagene Autoleucel

  • Experimental
    Arlocabtagene Autoleucel Cohort 2

    Biological: Arlocabtagene Autoleucel

Interventions

  • Specified dose on specified days

    Also known as: CC-95266,, GPRC5D CAR T cells, BMS-986393, Arlo-cel

06

What researchers measure

Primary outcomes

  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)

    Time frame: Up to approximately 5 years

Secondary outcomes

  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

    Time frame: 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)

    Time frame: Up to approximately 5 years

  3. Minimal residual disease (MRD) negative status

    Time frame: 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)

    Time frame: 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

    Time frame: Up to approximately 5 years

  6. Progression-free survival (PFS)

    Time frame: Up to approximately 5 years

  7. Overall survival (OS)

    Time frame: Up to approximately 5 years

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

    Time frame: Up to approximately 5 years

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

    Time frame: Up to approximately 5 years

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

    Time frame: Up to approximately 5 years

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

    Time frame: Up to approximately 5 years

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

    Time frame: Up to approximately 5 years

  13. Maximum observed plasma concentration (Cmax)

    Time frame: Up to approximately 5 years

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

    Time frame: Up to approximately 5 years

  15. Time of maximum observed plasma concentration (Tmax)

    Time frame: 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

    Time frame: Up to approximately 5 years

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

    Time frame: Up to approximately 5 years

07

Study locations

49 of 52 sites recruiting
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294-3300, United States
    Recruiting
    • Susan Bal, Site 0001 · Contact205-934-1908
  • Banner MD Anderson Cancer Center
    Gilbert, Arizona 85234, United States
    Recruiting
    • Ambuga Badari, Site 0025 · Contact
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
    Recruiting
    • Sharmilan Thanendrarajan, Site 0037 · Contact000-000-0000
  • UCLA Hematology/Oncology - Westwood (Building 200 Suite 214)
    Los Angeles, California 90095, United States
    Recruiting
    • Sarah Larson, Site 0028 · Contact310-829-5471
  • UCSF Helen Diller Medical Center at Parnassus Heights
    San Francisco, California 94143, United States
    Recruiting
    • Anupama Kumar, Site 0018 · Contact415-514-0768
  • Colorado Blood Cancer Institute
    Denver, Colorado 80218, United States
    Recruiting
    • Tara Gregory, Site 0049 · Contact720-754-4800
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224, United States
    Recruiting
    • Sikander Ailawadhi, Site 0062 · Contact904-953-0853
  • Miami Cancer Institute at Baptist Health, Inc.
    Miami, Florida 33176, United States
    Recruiting
    • George Nahas, Site 0045 · Contact201-310-8558
  • Moffitt Cancer Center
    Tampa, Florida 33612, United States
    Recruiting
    • Ciara Freeman, Site 0029 · Contact813-745-2475
  • Winship Cancer Institute of Emory University
    Atlanta, Georgia 30322, United States
    Recruiting
    • Nisha Joseph, Site 0009 · Contact502-608-5503
  • Northside Hospital
    Atlanta, Georgia 30342, United States
    Recruiting
    • Scott Solomon, Site 0004 · Contact404-255-1930
  • Northwestern Memorial Hospital
    Chicago, Illinois 60611, United States
    Recruiting
    • Seema Singhal, Site 0005 · Contact312-505-1290
  • University of Chicago Medical Center
    Chicago, Illinois 60637, United States
    Recruiting
    • Jennifer Cooperrider, Site 0056 · Contact
  • University of Iowa
    Iowa City, Iowa 52242, United States
    Recruiting
    • Christopher Strouse, Site 0019 · Contact630-917-8956
  • The University of Kansas Cancer Center - Westwood
    Westwood, Kansas 66205, United States
    Recruiting
    • Al-Ola Abdallah, Site 0016 · Contact918-261-6196
  • Norton Women's and Children's Hospital
    Louisville, Kentucky 40207, United States
    Recruiting
    • Don Stevens, Site 0026 · Contact502-899-3366
  • Local Institution - 0065
    Baltimore, Maryland 21218, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
    Recruiting
    • Diana Cirstea, Site 0039 · Contact617-724-4000
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
    Recruiting
    • Omar Nadeem, Site 0036 · Contact617-632-3000
  • Mayo Clinic in Rochester, Minnesota
    Rochester, Minnesota 55905, United States
    Recruiting
    • Taxiarchis Kourelis, Site 0033 · Contact855-776-0015
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
    Recruiting
    • Michael Slade, Site 0010 · Contact314-454-8304
  • Rutgers Cancer Institute of New Jersey
    New Brunswick, New Jersey 08901, United States
    Recruiting
    • Mansi Shah, Site 0034 · Contact732-209-5479
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
    Recruiting
    • Ehsan Malek, Site 0046 · Contact216-286-4441
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
    Recruiting
    • Adriana Rossi, Site 0002 · Contact646-962-6500
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
    Recruiting
    • Sham Mailankody, Site 0003 · Contact646-608-3712
  • University of North Carolina Medical Center
    Chapel Hill, North Carolina 27599-7305, United States
    Recruiting
    • Eben Lichtman, Site 0031 · Contact617-842-6051
  • Local Institution - 0067
    Charlotte, North Carolina 28204, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Oncology Hematology Care
    Cincinnati, Ohio 45242, United States
    Recruiting
    • Kruti Patel, Site 0054 · Contact888-961-4156
  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
    Columbus, Ohio 43210, United States
    Recruiting
    • Srinivas Devarakonda, Site 0032 · Contact570-423-0522
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
    Recruiting
    • Amrita Desai, Site 0038 · Contact503-494-0896
  • Sidney Kimmel Cancer Center - Jefferson Health
    Philadelphia, Pennsylvania 19107, United States
    Recruiting
    • Usama Gergis, Site 0070 · Contact917-698-4310
  • Tennessee Oncology
    Nashville, Tennessee 37203, United States
    Recruiting
    • Jesus Berdeja, Site 0066 · Contact615-329-0570
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
    Recruiting
    • Eden Biltibo, Site 0043 · Contact
  • Local Institution - 0069
    Austin, Texas 78704, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • UT Southwestern Medical Center
    Dallas, Texas 75390, United States
    Recruiting
    • Larry Anderson, Site 0035 · Contact214-648-5906
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
    Recruiting
    • Krina Patel, Site 0027 · Contact713-792-6662
  • Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute
    San Antonio, Texas 78229, United States
    Recruiting
    • Paul Shaughnessy, Site 0055 · Contact210-670-2313
  • LDS Hospital
    Salt Lake City, Utah 84143, United States
    Recruiting
    • Bradley Hunter, Site 0050 · Contact801-408-3729
  • Virginia Oncology Associates
    Norfolk, Virginia 23502, United States
    Recruiting
    • gary Simmons, Site 0068 · Contact757-461-7084
  • Fred Hutchinson Cancer Center
    Seattle, Washington 98109, United States
    Recruiting
    • Rahul Banerjee, Site 0011 · Contact206-606-1453
  • University of Wisconsin Carbone Cancer Center - University Hospital
    Madison, Wisconsin 53792, United States
    Recruiting
    • Zhubin Gahvari, Site 0015 · Contact608-262-9317
  • Royal Prince Alfred Hospital
    Camperdown, New South Wales 2050, Australia
    Recruiting
    • Joy Ho, Site 0077 · Contact+61295158031
  • Royal Brisbane and Women's Hospital
    Brisbane, Queensland 4029, Australia
    Recruiting
    • Nicholas Weber, Site 0075 · Contact+61736460818
  • The Alfred Hospital
    Melbourne, Victoria 3004, Australia
    Recruiting
    • Sueh-Li Lim, Site 0074 · Contact0403374221
  • St Vincent's Hospital
    Melbourne, Victoria 3065, Australia
    Recruiting
    • Hang Quach, Site 0076 · Contact+61392313189
  • Arthur J.E. Child Comprehensive Cancer Centre
    Calgary, Alberta T2N 5G2, Canada
    Recruiting
    • Nizar Bahlis, Site 0020 · Contact4032202801
  • McGill University Health Centre
    Montreal, Quebec H4A 3J1, Canada
    Recruiting
    • Michael Sebag, Site 0021 · Contact514-934-1934-31558
  • Nagoya City University Hospital
    Nagoya, Aichi-ken 467-8602, Japan
    Recruiting
    • Shinsuke Iida, Site 0057 · Contact0057
  • Hyogo Medical University Hospital
    Nishinomiya, Hyōgo 663-8501, Japan
    Recruiting
    • Satoshi Yoshihara, Site 0058 · Contact0058
  • Japanese Red Cross Medical Center
    Shibuya-ku, Tokyo 150-8935, Japan
    Recruiting
    • Tadao Ishida, Site 0060 · Contact0060
  • Chiba University Hospital
    Chiba, 260-8677, Japan
    Recruiting
    • Emiko Sakaida, Site 0061 · Contact0061
  • University Hospital,Kyoto Prefectural University of Medicine
    Kyoto, 602-8566, Japan
    Recruiting
    • Junya Kuroda, Site 0059 · Contact0059
08

References and documents

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: See Plan Description

Access criteria: See Plan Description

Data sharing details ↗ · www.bms.com

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2024 to primary completion in Jul 2026, 28 months.

Of 93 industry-sponsored phase 2 interventional studies under Multiple Myeloma, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 77. This study's 28 months is below that.

Counting every sponsor, half of 505 studies reached it within 57 months; a quarter within 35 and three quarters within 95.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2024
First posted
Mar 7, 2024
StartActual
Mar 21, 2024
Primary completionActual
Jul 31, 2026
CompletionEst.
Jun 30, 2032
Last update
Oct 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Site contacts
Changed at 1 site. See the sites
Show the site
  • St Vincent's Hospital · Melbourne, AustraliaContact •••2698→•••3189
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Site contacts Changed at 1 site. See the sites
    Show the site
    • St Vincent's Hospital · Melbourne, AustraliaContact •••2698→•••3189
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06297226
Responsible party
Sponsor
First posted
Mar 7, 2024
Start date
Mar 21, 2024
Primary completion
Jul 31, 2026
Completion
Jun 30, 2032 (estimated)
Last update
Oct 6, 2026

Study contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Contact
Clinical.Trials@bms.com
855-907-3286
First line of the email MUST contain NCT # and Site #.
Contact
Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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