Recruiting
Phase 1

BMS-986453

Sponsor:

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

Code:

NCT06153251

Conditions

Relapsed and/or Refractory Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMS-986453

Fludarabine

Cyclophosphamide

Study Details

Brief summary:

The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).

Conditions

Relapsed and/or Refractory Multiple Myeloma

Study ID

NCT06153251

Start date

Jan 23, 2024

Status verified date

Mar, 2026

Completion date

May 2, 2030

Anticipated

Primary completion date

May 2, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants must have a diagnosis of multiple myeloma with relapsed and/or refractory disease.
  • Participants must have confirmed progressive disease on or within 12 months (measured from the last dose) of completing treatment with the last anti-myeloma treatment regimen before study entry.
  • Participants in Part A and Part B Cohort 1 and in Part B Cohort 2 must have relapsed/refractory multiple myeloma and received previous antimyeloma therapy, including a proteasome inhibitor and an immunomodulatory agent.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Participants must have adequate organ function.

Exclusion Criteria:

  • Participants must not have any known active or history of central nervous system (CNS) involvement of multiple myeloma.
  • Participants must not have active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis.
  • Participants must not have a history or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or cerebellar disease, or presence of clinically active psychosis.
  • Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Enrollment

187 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Administration of BMS-986453

Interventions

BMS-986453

Specified dose on specified days

Fludarabine

Specified dose on specified days

Cyclophosphamide

Specified dose on specified days

Primary outcome measure

  • Number of participants with treatment-emergent adverse events (AEs) [ Time Frame: Up to 4 years ]
  • Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 4 years ]
  • Number of participants with AEs leading to discontinuation [ Time Frame: Up to 4 years ]
  • Number of participants with AEs leading to death [ Time Frame: Up to 4 years ]
  • Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Up to 4 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

Contacts

Luciano Costa, Site 0001

205-934-9695

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

MURALI JANAKIRAM, Site 0003

626-201-5710

UCSF Helen Diller Medical Center at Parnassus Heights

Recruiting

San Francisco, California, United States, 94143

Contacts

Alfred Chung, Site 0011

000-000-0000

Stanford University Medical Center

Recruiting

Stanford, California, United States, 94305

Contacts

Surbhi Sidana, Site 0006

650-723-0822

Colorado Blood Cancer Institute

Recruiting

Denver, Colorado, United States, 80218

Contacts

Tara Gregory, Site 0013

720-754-4800

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Noffar Bar, Site 0005

000-000-0000

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Doris Hansen, Site 0016

601-812-3214

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Clifton Mo, Site 0023

202-689-9961

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Adriana Rossi, Site 0010

646-962-6500

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Sham Mailankody, Site 0004

646-608-3712

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Jesus Berdeja, Site 0020

615-329-0570

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

Swathi Namburi, Site 0012

206-386-6738

More Information

Sponsor

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

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

  • Dual Targeting
  • BCMAxGPRC5D
  • GPRC5DxBCMA
  • BMS-986453
  • CAR T
  • CART
  • Multiple Myeloma
  • Relapsed and/or Refractory

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 2026-03-18.