Recruiting

Phase 1

BMS-986393A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma

Sponsor:

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

Code:

NCT06121843

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMS-986393

Alnuctamab

Mezigdomide

Iberdomide

Elranatamab

Study Details

Brief summary:

The purpose of this study is to establish a safe and tolerable dose of arlocabtagene autoleucel (BMS-986393) in combinations with alnuctamab, mezigdomide, iberdomide, and elranatamab in participants with relapsed and/or refractory multiple myeloma (RRMM).

Conditions

Multiple Myeloma

Study ID

NCT06121843

Start date

Feb 22, 2024

Status verified date

Jul, 2026

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

History of relapsed and/or refractory multiple myeloma (RRMM) treated with at least 3 (Part 1), history of RRMM or at least 1 but not greater than 3 prior anti-myeloma treatment (PAMT) regimens (Part 2, Arms A, B, C, and D); history of quadruple class exposed RRMM having received BCMA TCE as the most recent line of therapy (Part 2, Arm E).
Measurable multiple myeloma (MM) as per International Myeloma Working Group (IMWG).
Eastern Cooperative Oncology Group performance status of 0-1.
Adherence to contraception requirements.

Exclusion Criteria:

Prior treatment with alnuctamab (Arm A), mezigdomide (Arms B and E), iberdomide (Arm C), elranatamab (Arm D) or BCMA-targeting therapy (Part 2 Arms A and D).
Prior treatment with GPRC5D-targeting therapies as of Protocol Amendment 02 (Part 1 and Part 2).
Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Enrollment

187 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: BMS-986393 + Alnuctamab

experimental: Arm B: BMS-986393 + Mezigdomide

experimental: Arm C: BMS-986393 + Iberdomide

experimental: Arm D: BMS-986393 + Elranatamab

experimental: Arm E: BMS-986393 + Mezigdomide and Dexamethasone

Interventions

BMS-986393

Specified dose on specified days

Alnuctamab

Specified dose on specified days

Mezigdomide

Specified dose on specified days

Iberdomide

Specified dose on specified days

Elranatamab

Specified dose on specified days

Dexamethasone

Specified dose on specified days

Primary outcome measure

Incidence of adverse events (AEs) [ Time Frame: Up to 2 years ]
Incidence of serious adverse events (SAEs) [ Time Frame: Up to 2 years ]
Incidence of adverse events of special interest (AESI) [ Time Frame: Up to 2 years ]
Incidence of AEs leading to discontinuation [ Time Frame: Up to 2 years ]
Number of Deaths [ Time Frame: Up to 2 years ]
Establish recommended Phase 2 dose (RP2D) [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294-3300

Contacts

Susan Bal, Site 0008

Mayo Clinic in Arizona - Phoenix

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Julia Wiedmeier-Nutor, Site 0002

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Myo Htut, Site 0028

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Sikander Ailawadhi, Site 0005

Northside Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Scott Solomon, Site 0006

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Jacalyn Rosenblatt, Site 0027

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Omar Nadeem, Site 0011

Mayo Clinic in Rochester, Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Taxiarchis Kourelis, Site 0001

University Of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Christopher D'Angelo, Site 0010

John Theurer Cancer Center at Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601-2191

Contacts

David Siegel, Site 0004

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Ehsan Malek, Site 0007

Laura and Isaac Perlmutter Cancer Center

Recruiting

New York, New York, United States, 10016

Contacts

Jingmei Hsu, Site 0022

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Sham Mailankody, Site 0012

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Jesus Berdeja, Site 0025

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Krina Patel, Site 0003

Arthur J.E. Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Contacts

Nizar Bahlis, Site 0013

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Christine Chen, Site 0024

More Information

Sponsor

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

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

BMS-986393
Relapsed Multiple Myeloma
Refractory Multiple Myeloma
First-in-human
Alnuctamab
Mezigdomide
Iberdomide
CC-95266
GPRC5D
GPRC5D CAR T
Cell Therapy
CAR T cell therapy
Combination therapy
elranatamab
arlocabtagene autoleucel
arlo-cel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company on 2026-07-16.