Recruiting
Phase 2

Arlocabtagene Autoleucel

Sponsor:

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

Code:

NCT06297226

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Arlocabtagene Autoleucel

Study Details

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.

Conditions

Multiple Myeloma

Study ID

NCT06297226

Start date

Mar 21, 2024

Status verified date

Sep, 2026

Completion date

Jun 30, 2032

Anticipated

Primary completion date

Jul 31, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

230 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arlocabtagene Autoleucel Cohort 1

experimental: Arlocabtagene Autoleucel Cohort 2

Interventions

Arlocabtagene Autoleucel

Specified dose on specified days

Primary outcome measure

  • Cohort 1: Best overall response (BOR) of partial response (PR) or better [ Time Frame: Up to approximately 5 years ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294-3300

Contacts

Susan Bal, Site 0001

205-934-1908

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Sharmilan Thanendrarajan, Site 0037

000-000-0000

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

Recruiting

Los Angeles, California, United States, 90095

Contacts

Sarah Larson, Site 0028

310-829-5471

UCSF Helen Diller Medical Center at Parnassus Heights

Recruiting

San Francisco, California, United States, 94143

Contacts

Anupama Kumar, Site 0018

415-514-0768

Colorado Blood Cancer Institute

Recruiting

Denver, Colorado, United States, 80218

Contacts

Tara Gregory, Site 0049

720-754-4800

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Sikander Ailawadhi, Site 0062

904-953-0853

Miami Cancer Institute at Baptist Health, Inc.

Recruiting

Miami, Florida, United States, 33176

Contacts

George Nahas, Site 0045

201-310-8558

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Ciara Freeman, Site 0029

813-745-2475

Winship Cancer Institute of Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Nisha Joseph, Site 0009

502-608-5503

Northside Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Scott Solomon, Site 0004

404-255-1930

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Seema Singhal, Site 0005

312-505-1290

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Christopher Strouse, Site 0019

630-917-8956

The University of Kansas Cancer Center - Westwood

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Al-Ola Abdallah, Site 0016

918-261-6196

Norton Women's and Children's Hospital

Recruiting

Louisville, Kentucky, United States, 40207

Contacts

Don Stevens, Site 0026

502-899-3366

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Diana Cirstea, Site 0039

617-724-4000

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Omar Nadeem, Site 0036

617-632-3000

Mayo Clinic in Rochester, Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Taxiarchis Kourelis, Site 0033

855-776-0015

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Michael Slade, Site 0010

314-454-8304

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Mansi Shah, Site 0034

732-209-5479

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Ehsan Malek, Site 0046

216-286-4441

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Adriana Rossi, Site 0002

646-962-6500

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Sham Mailankody, Site 0003

646-608-3712

University of North Carolina Medical Center

Recruiting

Chapel Hill, North Carolina, United States, 27599-7305

Contacts

Eben Lichtman, Site 0031

617-842-6051

Oncology Hematology Care

Recruiting

Cincinnati, Ohio, United States, 45242

Contacts

Kruti Patel, Site 0054

888-961-4156

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

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Srinivas Devarakonda, Site 0032

570-423-0522

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Amrita Desai, Site 0038

503-494-0896

Sidney Kimmel Cancer Center - Jefferson Health

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Usama Gergis, Site 0070

917-698-4310

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Jesus Berdeja, Site 0066

615-329-0570

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Larry Anderson, Site 0035

214-648-5906

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Krina Patel, Site 0027

713-792-6662

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

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Paul Shaughnessy, Site 0055

210-670-2313

LDS Hospital

Recruiting

Salt Lake City, Utah, United States, 84143

Contacts

Bradley Hunter, Site 0050

801-408-3729

Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

gary Simmons, Site 0068

757-461-7084

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Rahul Banerjee, Site 0011

206-606-1453

University of Wisconsin Carbone Cancer Center - University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Zhubin Gahvari, Site 0015

608-262-9317

Arthur J.E. Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Contacts

Nizar Bahlis, Site 0020

4032202801

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Michael Sebag, Site 0021

514-934-1934-31558

More Information

Sponsor

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

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company on 2026-09-14.