Multiple MyelomaPhase 1NCT06121843
A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma
A Phase 1 study testing BMS-986393, Alnuctamab and Mezigdomide in people with Multiple Myeloma, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 19 sites in 2 countries.
Trial summary
The purpose of this study is to establish a safe and tolerable dose of arlocabtagene autoleucel (BMS-986393) in combinations with alnuctamab, mezigdomide, iberdomide, and elranatamab 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
- Multiple Myeloma
- What is being tested?
- BMS-986393, Alnuctamab and Mezigdomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 22 Feb 2024to 1 Aug 2028
- 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
- History of relapsed and/or refractory multiple myeloma (RRMM) treated with at least 3 (Part 1), history of RRMM or at least 1 but not greater than 3 prior anti-myeloma treatment (PAMT) regimens (Part 2, Arms A, B, C, and D); history of quadruple class exposed RRMM having received BCMA TCE as the most recent line of therapy (Part 2, Arm E).
- Measurable multiple myeloma (MM) as per International Myeloma Working Group (IMWG).
- Eastern Cooperative Oncology Group performance status of 0-1.
- Adherence to contraception requirements.
Who cannot join
- Prior treatment with alnuctamab (Arm A), mezigdomide (Arms B and E), iberdomide (Arm C), elranatamab (Arm D) or BCMA-targeting therapy (Part 2 Arms A and D).
- Prior treatment with GPRC5D-targeting therapies as of Protocol Amendment 02 (Part 1 and Part 2).
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
19 sites in 2 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 2 countries
United States17 sites, 15 recruiting
- Recruiting
Northside Hospital
Atlanta, Georgia, 30342
Scott Solomon, Site 0006, 404-255-1930
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
Susan Bal, Site 0008, 205-934-1908
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Jacalyn Rosenblatt, Site 0027, 617-667-9920
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Omar Nadeem, Site 0011, 617-632-3000
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Ehsan Malek, Site 0007, 216-286-4441
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Myo Htut, Site 0028, 626-256-4673
- Recruiting
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601-2191
David Siegel, Site 0004, 551-996-8704
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Krina Patel, Site 0003, 713-792-6662
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Sikander Ailawadhi, Site 0005, 904-953-0853
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
Jesus Berdeja, Site 0025, 615-329-0570
- Recruiting
Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016
Jingmei Hsu, Site 0022, 646-501-4848
- Completed
Local Institution - 0009
New York, New York, 10032
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Sham Mailankody, Site 0012, 646-608-3712
- Recruiting
University Of Nebraska Medical Center
Omaha, Nebraska, 68198
Christopher D'Angelo, Site 0010, 402-559-8110
- Recruiting
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona, 85054
Julia Wiedmeier-Nutor, Site 0002, 855-776-0015
- Withdrawn
Local Institution - 0023
Pittsburgh, Pennsylvania, 15232
- Recruiting
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905
Taxiarchis Kourelis, Site 0001, 855-776-0015
Canada2 sites, 2 recruiting
- Recruiting
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Nizar Bahlis, Site 0013, 4032202801
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Christine Chen, Site 0024, 4169464501
About this study
Official title: A Phase 1, Multicenter, Open-label Study to Evaluate the Safety and Preliminary Efficacy of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma and Determine the Recommended Dose for Each Add-on Investigational Component
The purpose of this study is to establish a safe and tolerable dose of arlocabtagene autoleucel (BMS-986393) in combinations with alnuctamab, mezigdomide, iberdomide, and elranatamab in participants with relapsed and/or refractory multiple myeloma (RRMM).
- Conditions
- Multiple Myeloma
- Being tested
- BMS-986393, Alnuctamab, Mezigdomide, Iberdomide, Elranatamab
- Keywords
- BMS-986393, Relapsed Multiple Myeloma, Refractory Multiple Myeloma, First-in-human, Alnuctamab, Mezigdomide, Iberdomide, CC-95266, GPRC5D, GPRC5D CAR T, Cell Therapy, CAR T cell therapy, Combination therapy, elranatamab, arlocabtagene autoleucel, arlo-cel
- 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-986393Drug
Also called CC-95266, Arlocabtagene autoleucel, arlo-cel
Specified dose on specified days
AlnuctamabDrug
Also called BMS-986349, CC-93269, EM901
Specified dose on specified days
MezigdomideDrug
Also called BMS-986348, CC-92480
Specified dose on specified days
IberdomideDrug
Also called BMS-986382, CC-220
Specified dose on specified days
ElranatamabDrug
Also called Elrexfio
Specified dose on specified days
DexamethasoneDrug
Also called Decadron
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A: BMS-986393 + Alnuctamab | Experimental | Not described Receives: Drug: BMS-986393; Drug: Alnuctamab |
| Arm B: BMS-986393 + Mezigdomide | Experimental | Not described Receives: Drug: BMS-986393; Drug: Mezigdomide |
| Arm C: BMS-986393 + Iberdomide | Experimental | Not described Receives: Drug: BMS-986393; Drug: Iberdomide |
| Arm D: BMS-986393 + Elranatamab | Experimental | Not described Receives: Drug: BMS-986393; Drug: Elranatamab |
| Arm E: BMS-986393 + Mezigdomide and Dexamethasone | Experimental | Not described Receives: Drug: BMS-986393; Drug: Mezigdomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Measured: Up to 2 years
Incidence of serious adverse events (SAEs)
Measured: Up to 2 years
Incidence of adverse events of special interest (AESI)
Measured: Up to 2 years
Incidence of AEs leading to discontinuation
Measured: Up to 2 years
Number of Deaths
Measured: Up to 2 years
Establish recommended Phase 2 dose (RP2D)
Measured: Up to 2 years
Secondary outcomes (6)
Overall response rate (ORR)
Measured: Up to 2 years
Complete response rate (CRR)
Measured: Up to 2 years
Very good partial response rate (VGPRR)
Measured: Up to 2 years
Maximum observed concentration (Cmax) of arlocabtagene autoleucel
Measured: Up to 2 years
Time of maximum observed concentration (tmax) of arlocabtagene autoleucel
Measured: Up to 2 years
Area under the concentration-time curve from time 0 to 28 days [AUC (0-28D)] of arlocabtagene autoleucel
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start22 Feb 2024
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 187 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- 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
- NCT06121843
- Sponsor's protocol ID
- CA088-1005
- Status last verified
- Jul 2026
- First submitted
- 2 Nov 2023
- Last updated
- 16 Jul 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-label Study to Evaluate the Safety and Preliminary Efficacy of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma and Determine the Recommended Dose for Each Add-on Investigational Component
- ClinicalTrials.gov ID
- NCT06121843
- Acronym / sponsor ID
- CA088-1005
- Conditions
- Multiple Myeloma
- Keywords
- BMS-986393, Relapsed Multiple Myeloma, Refractory Multiple Myeloma, First-in-human, Alnuctamab, Mezigdomide, Iberdomide, CC-95266
- 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
- 22 Feb 2024 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 8 Nov 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 establish a safe and tolerable dose of arlocabtagene autoleucel (BMS-986393) in combinations with alnuctamab, mezigdomide, iberdomide, and elranatamab in participants with relapsed and/or refractory multiple myeloma (RRMM).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm A: BMS-986393 + Alnuctamab | Experimental | Drug: BMS-986393, Drug: Alnuctamab |
| Arm B: BMS-986393 + Mezigdomide | Experimental | Drug: BMS-986393, Drug: Mezigdomide |
| Arm C: BMS-986393 + Iberdomide | Experimental | Drug: BMS-986393, Drug: Iberdomide |
| Arm D: BMS-986393 + Elranatamab | Experimental | Drug: BMS-986393, Drug: Elranatamab |
| Arm E: BMS-986393 + Mezigdomide and Dexamethasone | Experimental | Drug: BMS-986393, Drug: Mezigdomide, Drug: Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of relapsed and/or refractory multiple myeloma (RRMM) treated with at least 3 (Part 1), history of RRMM or at least 1 but not greater than 3 prior anti-myeloma treatment (PAMT) regimens (Part 2, Arms A, B, C, and D); history of quadruple class exposed RRMM having received BCMA TCE as the most recent line of therapy (Part 2, Arm E).
- Measurable multiple myeloma (MM) as per International Myeloma Working Group (IMWG).
- Eastern Cooperative Oncology Group performance status of 0-1.
- Adherence to contraception requirements.
Key exclusion criteria (3 listed)
- Prior treatment with alnuctamab (Arm A), mezigdomide (Arms B and E), iberdomide (Arm C), elranatamab (Arm D) or BCMA-targeting therapy (Part 2 Arms A and D).
- Prior treatment with GPRC5D-targeting therapies as of Protocol Amendment 02 (Part 1 and Part 2).
- 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-986393Also: CC-95266, Arlocabtagene autoleucel, arlo-celSpecified dose on specified days | Drug | Arm A: BMS-986393 + Alnuctamab, Arm B: BMS-986393 + Mezigdomide, Arm C: BMS-986393 + Iberdomide, Arm D: BMS-986393 + Elranatamab, Arm E: BMS-986393 + Mezigdomide and Dexamethasone |
| AlnuctamabAlso: BMS-986349, CC-93269, EM901Specified dose on specified days | Drug | Arm A: BMS-986393 + Alnuctamab |
| MezigdomideAlso: BMS-986348, CC-92480Specified dose on specified days | Drug | Arm B: BMS-986393 + Mezigdomide, Arm E: BMS-986393 + Mezigdomide and Dexamethasone |
| IberdomideAlso: BMS-986382, CC-220Specified dose on specified days | Drug | Arm C: BMS-986393 + Iberdomide |
| ElranatamabAlso: ElrexfioSpecified dose on specified days | Drug | Arm D: BMS-986393 + Elranatamab |
| DexamethasoneAlso: DecadronSpecified dose on specified days | Drug | Arm E: BMS-986393 + Mezigdomide and Dexamethasone |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Up to 2 years
Incidence of serious adverse events (SAEs)
Time frame: Up to 2 years
Incidence of adverse events of special interest (AESI)
Time frame: Up to 2 years
Incidence of AEs leading to discontinuation
Time frame: Up to 2 years
Number of Deaths
Time frame: Up to 2 years
Establish recommended Phase 2 dose (RP2D)
Time frame: Up to 2 years
6 secondary outcomes
Overall response rate (ORR)
Time frame: Up to 2 years
Complete response rate (CRR)
Time frame: Up to 2 years
Very good partial response rate (VGPRR)
Time frame: Up to 2 years
Maximum observed concentration (Cmax) of arlocabtagene autoleucel
Time frame: Up to 2 years
Time of maximum observed concentration (tmax) of arlocabtagene autoleucel
Time frame: Up to 2 years
Area under the concentration-time curve from time 0 to 28 days [AUC (0-28D)] of arlocabtagene autoleucel
Time frame: Up to 2 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 16 Jul 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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986393, Alnuctamab and Mezigdomide in people with Multiple Myeloma, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 19 sites in 2 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 4 inclusion and 3 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 16 Jul 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, Canada. 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?
Incidence of adverse events (AEs) (time frame: Up to 2 years). The study lists 6 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 16 Jul 2026.