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

NCT06297226 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CA088-1000
• Study Type: interventional
• Target: 230
• Locations: 4 countries
• Sites: 52

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

Keywords

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

Outcome Measures

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)

  Up to approximately 5 years

Secondary Outcomes (17)

• BOR of partial response (PR) or better

  Up to approximately 5 years

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

  Up to approximately 5 years

• Minimal residual disease (MRD) negative status

  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)

  Up to approximately 5 years

• Duration of response (DOR) assessed by an IRC

  Up to approximately 5 years

Study Arms (2)

Arlocabtagene Autoleucel Cohort 1

EXPERIMENTAL

Biological: Arlocabtagene Autoleucel

Arlocabtagene Autoleucel Cohort 2

EXPERIMENTAL

Biological: Arlocabtagene Autoleucel

Interventions

Arlocabtagene Autoleucel BIOLOGICAL

Specified dose on specified days

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

Arlocabtagene Autoleucel Cohort 1; Arlocabtagene Autoleucel Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Juno Therapeutics, Inc., a Bristol-Myers Squibb Company: lead

Study Sites (52)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

RECRUITING

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

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

Los Angeles, California, 90095, United States

RECRUITING

UCSF Helen Diller Medical Center at Parnassus Heights

San Francisco, California, 94143, United States

RECRUITING

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, 33176, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Northside Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

The University of Kansas Cancer Center - Westwood

Westwood, Kansas, 66205, United States

RECRUITING

Norton Women's and Children's Hospital

Louisville, Kentucky, 40207, United States

RECRUITING

Local Institution - 0065

Baltimore, Maryland, 21218, United States

WITHDRAWN

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, 55905, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

University of North Carolina Medical Center

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Local Institution - 0067

Charlotte, North Carolina, 28204, United States

WITHDRAWN

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

RECRUITING

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

Columbus, Ohio, 43210, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Local Institution - 0070

Philadelphia, Pennsylvania, 19107, United States

NOT YET RECRUITING

Tennessee Oncology

Nashville, Tennessee, 37203, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Local Institution - 0069

Austin, Texas, 78704, United States

WITHDRAWN

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

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

San Antonio, Texas, 78229, United States

RECRUITING

LDS Hospital

Salt Lake City, Utah, 84143, United States

RECRUITING

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

University Hospital and UW Health Clinics

Madison, Wisconsin, 53792, United States

RECRUITING

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

RECRUITING

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

St Vincent's Hospital

Melbourne, Victoria, 3065, Australia

RECRUITING

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada

RECRUITING

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

RECRUITING

Hyogo Medical University Hospital

Nishinomiya, Hyōgo, 663-8501, Japan

RECRUITING

Chiba University Hospital

Chiba, 260-8677, Japan

RECRUITING

University Hospital,Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

RECRUITING

Japanese Red Cross Medical Center

Tokyo, 150-8935, Japan

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 7, 2024
• Study Start: March 21, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2032
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

JP (5); AU (4); US (41); CA (2)