Study of BMS-986453 in Newly Diagnosed Multiple Myeloma

NCT07333261 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: IRB-300015643 (UAB2595)000551303
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 1b study evaluating if BMS-986453 is safe and effective in treating people who have newly diagnosed multiple myeloma after completing initial therapy (induction) when a stem cell transplant is not intended.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Evaluate the safety and tolerability of BMS-986453 in participants with NDMM.

  Baseline up to 5 years

Secondary Outcomes (10)

• Overall Response Rate (ORR)

  Baseline up to 5 years

• Overall Survival (OS)

  Baseline up to 5 years

• Progression Free Survival (PFS)

  Baseline up to 5 years

• Pharmacokinetics (PK)

  Baseline up to 2 years

• Complete response rate

  Baseline up to 5 years

Study Arms (1)

Single dose BMS-986453

EXPERIMENTAL

Participants will be treated with fludarabine IV (30 mg/m2/day) and cyclophosphamide IV (300 mg/m2/day) for 3 days prior to BMS-986453 infusion. A single dose of BMS-986453 administered by IV infusion.

Drug: BMS-986453

Interventions

BMS-986453 DRUG

Will be given as a single dose administered by IV infusion.

Single dose BMS-986453

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years with no upper age limit
• NDMM with indication for initiation of therapy diagnosed within last 12 months. Pretreatment parameters necessary for disease characterization and response assessment must be available.
• Not eligible for ASCT by institutional criteria or deferring ASCT due to personal preference.
• ECOG performance status 0-1
• Adequate organ function

You may not qualify if:

• Known active or history of central nervous system (CNS) involvement of MM.
• Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS or clinically significant amiloidosis.
• Prior history of other malignancies
• Uncontrolled infection

Sponsors & Collaborators

• Susan Bal: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

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

Study Officials

• Susan Bal, MD

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Luciano A Costa, MD

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Bal, MD

CONTACT

(205) 934-7645; susanbal@uabmc.edu

Margaret Thomas, MPH

CONTACT

margaretathomas@uabmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a single center, open-label, Phase 1b study to determine the safety, and preliminary efficacy of BMS-986453, a dual targeting CAR-T cell product targeting BCMA and GPRC5D, in participants with NDMM in whom ASCT is not planned. The study will evaluate the safety, PK, pharmacodynamic, and preliminary efficacy of BMS-986453 at the RP2D. All treated participants will complete three periods: pre-treatment, treatment, and post- treatment follow-up.

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 12, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2041
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)