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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07333261

Enrollment

Registered

2026-01-12

Start date

2026-02-09

Completion date

2041-12-01

Last updated

2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

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.

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.

Interventions

DRUGBMS-986453

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Baseline up to 5 years	Evaluate the safety and tolerability of BMS-986453 in participants with NDMM.

Secondary

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

Countries

United States

Contacts

CONTACTSusan Bal, MD

susanbal@uabmc.edu(205) 934-7645

CONTACTMargaret Thomas, MPH

margaretathomas@uabmc.edu

PRINCIPAL_INVESTIGATORSusan Bal, MD

The University of Alabama at Birmingham

PRINCIPAL_INVESTIGATORLuciano A Costa, MD