RecruitingInterventionalPhase 1

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

NCT ID: NCT07333261Sponsor: Susan BalLast updated: 2026-02-13

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.

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.

Arms & interventions

DrugBMS-986453
Will be given as a single dose administered by IV infusion.

Outcome measures

Primary

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.
Time frame: Baseline up to 5 years

Secondary

Overall Response Rate (ORR)
Time frame: Baseline up to 5 years
Overall Survival (OS)
Time frame: Baseline up to 5 years
Progression Free Survival (PFS)
Time frame: Baseline up to 5 years
Pharmacokinetics (PK)
Time frame: Baseline up to 2 years
Complete response rate
Time frame: Baseline up to 5 years
MRD negativity
Time frame: Baseline up to 5 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to 15 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to 15 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to 15 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to 15 years

Eligibility criteria

Sex: AllAge: 19 Years and olderHealthy volunteers: No

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 locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294

Recruiting

Susan Bal, MD · Contact

2059347645 susanbal@uabmc.edu

Luciano J Costa, MD, PhD · Contact

ljcosta@uabmc.edu

Susan Bal, MD · Principal Investigator

Luciano J Costa, MD, PhD · Sub Investigator

Kelly Godby, MD · Sub Investigator

Gayathri Ravi, MD · Sub Investigator

Heidi Worth, MD · Sub Investigator