Relapsed and/or Refractory Multiple MyelomaPhase 1NCT06153251
A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma
A Phase 1 study testing BMS-986453, Fludarabine and Cyclophosphamide in people with Relapsed and/or Refractory Multiple Myeloma, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 19 sites in 4 countries.
Trial summary
The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed and/or Refractory Multiple Myeloma
- What is being tested?
- BMS-986453, Fludarabine and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 19 sitesin 4 countries
- Study dates
- 23 Jan 2024to 2 May 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have a diagnosis of multiple myeloma with relapsed and/or refractory disease.
- Participants must have confirmed progressive disease on or within 12 months (measured from the last dose) of completing treatment with the last anti-myeloma treatment regimen before study entry.
- Participants in Part A and Part B Cohort 1 and in Part B Cohort 2 must have relapsed/refractory multiple myeloma and received previous antimyeloma therapy, including a proteasome inhibitor and an immunomodulatory agent.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Participants must have adequate organ function.
Who cannot join
- Participants must not have any known active or history of central nervous system (CNS) involvement of multiple myeloma.
- Participants must not have active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis.
- Participants must not have a history or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or cerebellar disease, or presence of clinically active psychosis.
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
19 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
19 sites in 4 countries
United States13 sites, 13 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Luciano Costa, Site 0001, 205-934-9695
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Clifton Mo, Site 0023, 202-689-9961
- Recruiting
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Tara Gregory, Site 0013, 720-754-4800
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
MURALI JANAKIRAM, Site 0003, 626-201-5710
- Not yet recruiting
Local Institution - 0008
Nashville, Tennessee, 37203
Site 0008
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
Jesus Berdeja, Site 0020, 615-329-0570
- Recruiting
Yale Cancer Center
New Haven, Connecticut, 06520
Noffar Bar, Site 0005, 000-000-0000
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Adriana Rossi, Site 0010, 646-962-6500
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Sham Mailankody, Site 0004, 646-608-3712
- Recruiting
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, 94143
Alfred Chung, Site 0011, 000-000-0000
- Recruiting
Swedish Medical Center
Seattle, Washington, 98104
Swathi Namburi, Site 0012, 206-386-6738
- Recruiting
Stanford University Medical Center
Stanford, California, 94305
Surbhi Sidana, Site 0006, 650-723-0822
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Doris Hansen, Site 0016, 601-812-3214
Germany3 sites, 3 recruiting
- Recruiting
Universitaetsklinikum Koeln
Cologne, 50937
Christof Scheid, Site 0017, 492214786296
- Recruiting
Universitaetsklinikum Heidelberg
Heidelberg, D-69120
Marc-Steffen Raab, Site 0021, 496221565427
- Recruiting
Universitaetsklinikum Wuerzburg
Würzburg, 97080
Hermann Einsele, Site 0018, +4994120140202
Spain2 sites, 2 recruiting
- Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Paula Rodriguez Otero, Site 0015, +0034948254000 0 000
- Recruiting
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, 37007
Maria Victoria Mateos Manteca, Site 0014, 34923291100
France1 site, 1 recruiting
- Recruiting
Hôpital Saint-Louis
Paris, 75010
Bertrand Arnulf, Site 0019, 33142499472
About this study
Official title: A Phase 1, Open-Label, Dose-Finding Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma
The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).
- Being tested
- BMS-986453, Fludarabine, Cyclophosphamide
- Keywords
- Dual Targeting, BCMAxGPRC5D, GPRC5DxBCMA, BMS-986453, CAR T, CART, Multiple Myeloma, Relapsed and/or Refractory
- 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
Specified dose on specified days
FludarabineDrug
Also called FludAra, Oforta
Specified dose on specified days
CyclophosphamideDrug
Also called Cytoxan, Cytoxan Lyophilized, Neosar
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Administration of BMS-986453 | Experimental | Not described Receives: Drug: BMS-986453; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (AEs)
Measured: Up to 4 years
Number of participants with serious adverse events (SAEs)
Measured: Up to 4 years
Number of participants with AEs leading to discontinuation
Measured: Up to 4 years
Number of participants with AEs leading to death
Measured: Up to 4 years
Number of participants with dose-limiting toxicities (DLTs)
Measured: Up to 4 years
Secondary outcomes (14)
Maximum observed concentration (Cmax)
Measured: Up to 4 years
Time of maximum observed concentration (Tmax)
Measured: Up to 4 years
Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))
Measured: Up to 4 years
Overall response rate (ORR)
Measured: Up to 4 years
Complete response rate (CRR)
Measured: Up to 4 years
Number of participants with very good partial response (VGPR) or better
Measured: Up to 4 years
Progression-free survival (PFS)
Measured: Up to 4 years
Overall survival (OS)
Measured: Up to 4 years
Time to response (TTR)
Measured: Up to 4 years
Time to complete response (TTCR)
Measured: Up to 4 years
Duration of response (DOR)
Measured: Up to 4 years
Duration of complete response (DOCR)
Measured: Up to 4 years
Persistence of BMS-986453 in peripheral blood
Defined as a transgene count greater than or equal to the lower limit of detection (LLOD)
Measured: Up to 4 years
Expansion rate
Defined as Cmax divided by Tmax
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start23 Jan 2024
- Primary completion2 May 2030 (estimated)
- Study completion2 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed and/or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 187 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153251
- Sponsor's protocol ID
- CA119-0002
- Other IDs
- 2023-506003-26-00, 2023
- Status last verified
- Mar 2026
- First submitted
- 22 Nov 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose-Finding Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06153251
- Acronym / sponsor ID
- CA119-0002
- Keywords
- Dual Targeting, BCMAxGPRC5D, GPRC5DxBCMA, BMS-986453, CAR T, CART, Multiple Myeloma, Relapsed and/or Refractory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 187 participants (estimated)
- Lead sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 2 May 2030 (estimated)
- Study completion
- 2 May 2030 (estimated)
- First posted
- 1 Dec 2023 (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.
The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of BMS-986453 | Experimental | Drug: BMS-986453, Drug: Fludarabine, Drug: Cyclophosphamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must have a diagnosis of multiple myeloma with relapsed and/or refractory disease.
- Participants must have confirmed progressive disease on or within 12 months (measured from the last dose) of completing treatment with the last anti-myeloma treatment regimen before study entry.
- Participants in Part A and Part B Cohort 1 and in Part B Cohort 2 must have relapsed/refractory multiple myeloma and received previous antimyeloma therapy, including a proteasome inhibitor and an immunomodulatory agent.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Participants must have adequate organ function.
Key exclusion criteria (4 listed)
- Participants must not have any known active or history of central nervous system (CNS) involvement of multiple myeloma.
- Participants must not have active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis.
- Participants must not have a history or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or cerebellar disease, or presence of clinically active psychosis.
- 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-986453Specified dose on specified days | Drug | Administration of BMS-986453 |
| FludarabineAlso: FludAra, OfortaSpecified dose on specified days | Drug | Administration of BMS-986453 |
| CyclophosphamideAlso: Cytoxan, Cytoxan Lyophilized, NeosarSpecified dose on specified days | Drug | Administration of BMS-986453 |
Primary outcome
Number of participants with treatment-emergent adverse events (AEs)
Time frame: Up to 4 years
Number of participants with serious adverse events (SAEs)
Time frame: Up to 4 years
Number of participants with AEs leading to discontinuation
Time frame: Up to 4 years
Number of participants with AEs leading to death
Time frame: Up to 4 years
Number of participants with dose-limiting toxicities (DLTs)
Time frame: Up to 4 years
14 secondary outcomes
Maximum observed concentration (Cmax)
Time frame: Up to 4 years
Time of maximum observed concentration (Tmax)
Time frame: Up to 4 years
Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))
Time frame: Up to 4 years
Overall response rate (ORR)
Time frame: Up to 4 years
Complete response rate (CRR)
Time frame: Up to 4 years
Number of participants with very good partial response (VGPR) or better
Time frame: Up to 4 years
Progression-free survival (PFS)
Time frame: Up to 4 years
Overall survival (OS)
Time frame: Up to 4 years
Time to response (TTR)
Time frame: Up to 4 years
Time to complete response (TTCR)
Time frame: Up to 4 years
Duration of response (DOR)
Time frame: Up to 4 years
Duration of complete response (DOCR)
Time frame: Up to 4 years
Persistence of BMS-986453 in peripheral blood
Time frame: Up to 4 years
Expansion rate
Time frame: Up to 4 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 18 Mar 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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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.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
19 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986453, Fludarabine and Cyclophosphamide in people with Relapsed and/or Refractory Multiple Myeloma, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 19 sites in 4 countries.
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 4 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Germany, Spain, France. 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?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events (AEs) (time frame: Up to 4 years). The study lists 5 primary outcomes in all. 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 18 Mar 2026.