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

NCT ID: NCT06297226

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-21

Study Completion Date

2032-06-30

Brief Summary

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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

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arlocabtagene Autoleucel Cohort 1

Group Type EXPERIMENTAL

Arlocabtagene Autoleucel

Intervention Type BIOLOGICAL

Specified dose on specified days

Arlocabtagene Autoleucel Cohort 2

Group Type EXPERIMENTAL

Arlocabtagene Autoleucel

Intervention Type BIOLOGICAL

Specified dose on specified days

Interventions

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Arlocabtagene Autoleucel

Specified dose on specified days

Intervention Type BIOLOGICAL

Other Intervention Names

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

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Site Status RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status RECRUITING

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

Los Angeles, California, United States

Site Status RECRUITING

UCSF Helen Diller Medical Center at Parnassus Heights

San Francisco, California, United States

Site Status RECRUITING

Colorado Blood Cancer Institute

Denver, Colorado, United States

Site Status RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Site Status RECRUITING

Northside Hospital

Atlanta, Georgia, United States

Site Status RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status RECRUITING

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

University of Iowa

Iowa City, Iowa, United States

Site Status RECRUITING

The University of Kansas Cancer Center - Westwood

Westwood, Kansas, United States

Site Status RECRUITING

Norton Women's and Children's Hospital

Louisville, Kentucky, United States

Site Status RECRUITING

Local Institution - 0065

Baltimore, Maryland, United States

Site Status WITHDRAWN

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, United States

Site Status RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

University of North Carolina Medical Center

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Local Institution - 0067

Charlotte, North Carolina, United States

Site Status WITHDRAWN

Oncology Hematology Care

Cincinnati, Ohio, United States

Site Status RECRUITING

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

Columbus, Ohio, United States

Site Status RECRUITING

Oregon Health and Science University

Portland, Oregon, United States

Site Status RECRUITING

Local Institution - 0070

Philadelphia, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

Tennessee Oncology

Nashville, Tennessee, United States

Site Status RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status RECRUITING

Local Institution - 0069

Austin, Texas, United States

Site Status WITHDRAWN

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

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

San Antonio, Texas, United States

Site Status RECRUITING

LDS Hospital

Salt Lake City, Utah, United States

Site Status RECRUITING

Virginia Oncology Associates

Norfolk, Virginia, United States

Site Status RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Site Status RECRUITING

University Hospital and UW Health Clinics

Madison, Wisconsin, United States

Site Status RECRUITING

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Site Status RECRUITING

Local Institution - 0075

Brisbane, Queensland, Australia

Site Status NOT_YET_RECRUITING

The Alfred Hospital

Melbourne, Victoria, Australia

Site Status RECRUITING

St Vincent's Hospital

Melbourne, Victoria, Australia

Site Status RECRUITING

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Site Status RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

Site Status RECRUITING

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Site Status RECRUITING

Hyogo Medical University Hospital

Nishinomiya, Hyōgo, Japan

Site Status RECRUITING

Chiba University Hospital

Chiba, , Japan

Site Status RECRUITING

University Hospital,Kyoto Prefectural University of Medicine

Kyoto, , Japan

Site Status RECRUITING

Japanese Red Cross Medical Center

Tokyo, , Japan

Site Status RECRUITING

Countries

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United States Australia Canada Japan

Central Contacts

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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Role: CONTACT

855-907-3286

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

Role: CONTACT

Facility Contacts

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Susan Bal, Site 0001

Role: primary

205-934-1908

Ambuga Badari, Site 0025

Role: primary

Sharmilan Thanendrarajan, Site 0037

Role: primary

000-000-0000

Sarah Larson, Site 0028

Role: primary

310-829-5471

Anupama Kumar, Site 0018

Role: primary

415-514-0768

Tara Gregory, Site 0049

Role: primary

720-754-4800

Vivek Roy, Site 0062

Role: primary

000-000-0000

George Nahas, Site 0045

Role: primary

201-310-8558

Ciara Freeman, Site 0029

Role: primary

813-745-2475

Nisha Joseph, Site 0009

Role: primary

502-608-5503

Scott Solomon, Site 0004

Role: primary

404-255-1930

Seema Singhal, Site 0005

Role: primary

312-505-1290

Andrzej Jakubowiak, Site 0056

Role: primary

734-276-2912

Chris Strouse, Site 0019

Role: primary

630-917-8956

Leyla Shune, Site 0016

Role: primary

913-588-6029

Don Stevens, Site 0026

Role: primary

502-899-3366

Diana Cirstea, Site 0039

Role: primary

617-724-4000

Omar Nadeem, Site 0036

Role: primary

617-632-3000

Taxiarchis Kourelis, Site 0033

Role: primary

855-776-0015

Michael Slade, Site 0010

Role: primary

314-454-8304

Mansi Shah, Site 0034

Role: primary

732-209-5479

Ehsan Malek, Site 0046

Role: primary

216-286-4441

Adriana Rossi, Site 0002

Role: primary

646-962-6500

Sham Mailankody, Site 0003

Role: primary

646-608-3712

Eben Lichtman, Site 0031

Role: primary

617-842-6051

James Essell, Site 0054

Role: primary

513-686-5482

Srinivas Devarakonda, Site 0032

Role: primary

570-423-0522

Amrita Desai, Site 0038

Role: primary

503-494-0896

Site 0070

Role: primary

Jesus Berdeja, Site 0066

Role: primary

615-329-0570

Muhamed Baljevic, Site 0043

Role: primary

917-913-9166

Larry Anderson, Site 0035

Role: primary

214-648-5906

Krina Patel, Site 0027

Role: primary

713-792-6662

Paul Shaughnessy, Site 0055

Role: primary

210-670-2313

Bradley Hunter, Site 0050

Role: primary

801-408-3729

gary Simmons, Site 0068

Role: primary

757-461-7084

Rahul Banerjee, Site 0011

Role: primary

206-606-1453

Zhubin Gahvari, Site 0015

Role: primary

608-262-9317

Joy Ho, Site 0077

Role: primary

+61295158031

Site 0075

Role: primary

Shafqat Inam, Site 0074

Role: primary

0472591197

Hang Quach, Site 0076

Role: primary

61392882698

Nizar Bahlis, Site 0020

Role: primary

4032202801

Michael Sebag, Site 0021

Role: primary

514-934-1934-31558

Shinsuke Iida, Site 0057

Role: primary

81528515511

Satoshi Yoshihara, Site 0058

Role: primary

+81-90-2102-4734

Emiko Sakaida, Site 0061

Role: primary

+81432227171

Junya Kuroda, Site 0059

Role: primary

81752515740

Tadao Ishida, Site 0060

Role: primary

8133400104

Related Links

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Other Identifiers

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CA088-1000

Identifier Type: -

Identifier Source: org_study_id