Study of BMS-986453 in Newly Diagnosed Multiple Myeloma

A Phase 1b Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Newly Diagnosed Multiple Myeloma

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: BMS-986453

Detailed Description

This is an open-label study. The investigators propose to examine if BMS-986453 in people with newly diagnosed multiple myeloma may help control their disease for a prolonged period of time despite one-time treatment and challenge continuous treatment which is otherwise prescribed.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Margaret Thomas, MPH; Email: margaretathomas@uabmc.edu
• Study Contact Backup: Name: Susan Bal, MD; Phone Number: (205) 934-7645; Email: susanbal@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham
      • Principal Investigator: Susan Bal, MD
      • Sub-Investigator: Luciano J Costa, MD, PhD
      • Sub-Investigator: Kelly Godby, MD
      • Sub-Investigator: Gayathri Ravi, MD
      • Sub-Investigator: Heidi Worth, MD
      • Contact: Susan Bal, MD; Phone Number: 2059347645; Email: susanbal@uabmc.edu
      • Contact: Luciano J Costa, MD, PhD; Email: ljcosta@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single dose BMS-986453; 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; Will be given as a single dose administered by IV infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	Measure of clinical response.	Baseline up to 5 years
Overall Survival (OS)	Measure of clinical response.	Baseline up to 5 years
Progression Free Survival (PFS)	Measure of clinical response.	Baseline up to 5 years
Pharmacokinetics (PK)	Measures of observed blood concentration of BMS-968453.	Baseline up to 2 years
Complete response rate	Measures of clinical response.	Baseline up to 5 years
MRD negativity	Proportion of participants with overall MRD negativity, 9-month MRD negativity rates as well as sustained (>12 months) MRD negativity.	Baseline up to 5 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Assess long-term toxicity	Up to 15 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Assess lentiviral vector safety	Up to 15 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Assess disease status	Up to 15 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Assess survival after BMS-968453 infusion	Up to 15 years

Collaborators and Investigators

• Sponsor: Susan Bal
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Susan Bal, MD, The University of Alabama at Birmingham; Principal Investigator: Luciano A Costa, MD, The University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2041

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): January 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma
• Other Study ID Numbers: IRB-300015643 (UAB2595); 000551303 (Other Identifier: BMS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No