Multiple MyelomaPhase 1NCT07333261
Study of BMS-986453 in Newly Diagnosed Multiple Myeloma
A Phase 1 study testing BMS-986453 in people with Multiple Myeloma, run by Susan Bal at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- BMS-986453
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2026to Dec 2041
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- BMS-986453
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986453Drug
Will be given as a single dose administered by IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: BMS-986453 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 5 years
Secondary outcomes (10)
Overall Response Rate (ORR)
Measure of clinical response.
Measured: Baseline up to 5 years
Overall Survival (OS)
Measure of clinical response.
Measured: Baseline up to 5 years
Progression Free Survival (PFS)
Measure of clinical response.
Measured: Baseline up to 5 years
Pharmacokinetics (PK)
Measures of observed blood concentration of BMS-968453.
Measured: Baseline up to 2 years
Complete response rate
Measures of clinical response.
Measured: 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.
Measured: Baseline up to 5 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Assess long-term toxicity
Measured: Up to 15 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Assess lentiviral vector safety
Measured: Up to 15 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Assess disease status
Measured: Up to 15 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Assess survival after BMS-968453 infusion
Measured: Up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start9 Feb 2026
- Primary completionDec 2031 (estimated)
- Study completionDec 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Susan Bal
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Susan Bal, University of Alabama at Birmingham
- Investigators
- Susan Bal, MD, Principal investigator, The University of Alabama at BirminghamLuciano A Costa, MD, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333261
- Sponsor's protocol ID
- IRB-300015643 (UAB2595)
- Other IDs
- 000551303
- Status last verified
- Sep 2026
- First submitted
- 2 Dec 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Newly Diagnosed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07333261
- Acronym / sponsor ID
- IRB-300015643 (UAB2595)
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Susan BalUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2041 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single dose BMS-986453 | Experimental | Drug: BMS-986453Participants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
- Other protocol-defined Inclusion/Exclusion criteria apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986453Will be given as a single dose administered by IV infusion. | Drug | Single dose BMS-986453 |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Baseline up to 5 years
Evaluate the safety and tolerability of BMS-986453 in participants with NDMM.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Bal, MD principal investigator
The University of Alabama at Birmingham
Luciano A Costa, MD principal investigator
The University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986453 in people with Multiple Myeloma, run by Susan Bal at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (time frame: Baseline up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.