Multiple MyelomaPhase 1NCT03486067
Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma
A Phase 1 study testing CC-93269 in people with Multiple Myeloma, run by Celgene at 34 sites in 6 countries.
Trial summary
Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A and C) and expansion (Parts B and D), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma. 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?
- CC-93269
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 34 sitesin 6 countries
- Study dates
- 3 Apr 2018to 18 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 multiple myeloma with relapsed and refractory disease
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Must have measurable disease as determined by the central laboratory
Who cannot join
- Symptomatic central nervous system involvement of multiple myeloma
- Prior autologous stem cell transplant ≤ 3 months prior
- Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 12 months prior
- History of concurrent second cancers requiring active, ongoing systemic treatment
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
34 sites in 6 countries.
34 sites in 6 countries
United States9 sites
Local Institution - 106
Atlanta, Georgia, 30322
Local Institution - 105
Birmingham, Alabama, 35294
Local Institution - 109
Boston, Massachusetts, 02114
Local Institution - 111
Boston, Massachusetts, 02215
Henry Ford Medical Center - New Center One
Detroit, Michigan, 48202
Local Institution - 107
New Haven, Connecticut, 06510
Icahn School of Medicine at Mount Sinai Mount Sinai West
New York, New York, 10019
Local Institution - 103
San Francisco, California, 94143
Local Institution - 101
Seattle, Washington, 98104
Spain8 sites
Local Institution - 206
Barcelona, 08916
Local Institution - 208
Barcelona, 8035
Local Institution - 205
Madrid, 28007
Local Institution - 201
Pamplona, 31008
Local Institution - 203
Salamanca, 37007
Local Institution - 204
Santander, 39008
Local Institution - 207
Valencia, 46009
Local Institution - 202
Valencia, 46017
Germany5 sites
Local Institution - 305
Erlangen, 91054
Local Institution - 303
Hamburg, 20246
Local Institution - 302
Heidelberg, 69120
Local Institution - 306
München, 81675
Local Institution - 304
Tübingen, 72076
Japan5 sites
Local Institution - 605
Kamakura, 247-8533
Local Institution - 604
Kashiwa, 277-8577
Local Institution - 601
Kyoto, 602-8566
Local Institution - 602
Nagoya, Aichi-ken, 4678602
Local Institution - 603
Shibuya-ku, Tokyo, 1508935
Sweden4 sites
Local Institution - 504
Gothenborg, 413 46
Local Institution - 502
Lund, SE-221 85
Local Institution - 501
Stockholm, 141 86
Local Institution - 505
Uppsala, 75158
Italy3 sites
Local Institution - 402
Bergamo, 24127
Local Institution - 403
Meldola, 47014
Local Institution - 401
Milan, 20089
About this study
Official title: A Phase 1, Open-label, Dose Finding Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Subjects With Relapsed and Refractory Multiple Myeloma
Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A and C) and expansion (Parts B and D), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma.
Read the detailed description
The dose escalation parts (Part A with CC-93269 administered intravenous (IV) and Part C subcutaneous (SC)) of the study will evaluate the safety and tolerability of escalating doses of CC-93269, administered IV or SC, to determine the maximum tolerated dose (MTD) and non-tolerated dose (NTD) of CC-93269. The expansion parts (Part B and D) will further evaluate the safety and efficacy of CC-93269 administered IV or SC at or below the MTD in selected expansion cohorts of up to approximately 20 evaluable subjects each in order to determine the Recommended Phase 2 dose (RP2D).One or more dosing regimens may be selected for cohort expansion. All treatments will be administered in 28-day cycles for up to 5 years for subjects maintaining clinical benefit, or until confirmed disease progression, unacceptable toxicity, or subject/investigator decision to withdraw.
- Conditions
- Multiple Myeloma
- Being tested
- CC-93269
- Keywords
- Multiple Myeloma, BCMA X CD3 T Cell, Antibody, CC-93269, Relapsed and Refractory
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-93269Drug
Also called Alnuctamab
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Administration of CC-93269 | Experimental | Not described Receives: Drug: CC-93269 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Number of participants with Adverse Events
Measured: Up to approximately 63 months
Dose Limiting Toxicity (DLT)
Is defined as any of the toxicities occurring within the DLT assessment window (Cycle 1, Days 1 to 28) except those that are clearly and incontrovertibly due to extraneous causes.
Measured: Up to 60 months
Non-Tolerated Dose (NTD)
Is defined as a dose level at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in the DLT window.
Measured: Up to 60 months
Maximum Tolerated Dose (MTD)
Is defined as the last dose cohort below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during the DLT window.
Measured: Up to 60 months
Secondary outcomes (14)
Overall Response Rate (ORR)
Is defined as the proportion of subjects who achieve a partial response or better (eg, PR, VGPR, CR or sCR), according to International Myeloma Working Group (IMWG) response criteria.
Measured: Up to 60 months
Time to Response
Is defined as the time from the first CC-93269 dose date to the date of first documented response (PR or better).
Measured: Up to 60 months
Duration of Response
Is defined as the time from the earliest date of documented response (≥ PR) to the first documented disease progression or death, whichever occurs first.
Measured: Up to 60 months
Progression Free Survival
Is defined as the time from the first dose of CC-93269 to progressive disease or death from any cause, whichever occurs first.
Measured: Up to 60 months
Overall Survival
Is defined as the time from the first dose of CC-93269 to death from any cause.
Measured: Up to 60 months
Pharmacokinetics - Cmax
Maximum serum concentration of drug
Measured: Up to 60 months
Pharmacokinetics - Cmin
Minimum serum concentration of drug
Measured: Up to 60 months
Pharmacokinetics - AUC
Area under the curve
Measured: Up to 60 months
Pharmacokinetics - tmax
Time to peak (maximum) serum concentration
Measured: Up to 60 months
Pharmacokinetics - t1/2
Terminal Half-life
Measured: Up to 60 months
Pharmacokinetics - CL
Apparent total body clearance
Measured: Up to 60 months
Pharmacokinetics - Vss
Volume of distribution at steady-state
Measured: Up to 60 months
Pharmacokinetics - accumulation index of alnuctamab
Accumulation ratio of drug
Measured: Up to 60 months
Presence and frequency of anti-drug antibodies (ADA)
Detection of anti-drug antibodies in participants and frequency of anti-drug antibodies
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start3 Apr 2018
- Primary completion18 Mar 2025
- Study completion18 Mar 2025
Why it stopped: Business objectives have changed
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.
- More trials run by CelgeneThe 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
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- 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
- NCT03486067
- Sponsor's protocol ID
- CC-93269-MM-001
- Other IDs
- U1111-1210-6325, 2023-506564-14, 2023
- Status last verified
- Apr 2025
- First submitted
- 21 Mar 2018
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Dose Finding Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Subjects With Relapsed and Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03486067
- Acronym / sponsor ID
- CC-93269-MM-001
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, BCMA X CD3 T Cell, Antibody, CC-93269, Relapsed and Refractory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 18 Mar 2025 (actual)
- First posted
- 3 Apr 2018 (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.
Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A and C) and expansion (Parts B and D), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma.
Detailed description
The dose escalation parts (Part A with CC-93269 administered intravenous (IV) and Part C subcutaneous (SC)) of the study will evaluate the safety and tolerability of escalating doses of CC-93269, administered IV or SC, to determine the maximum tolerated dose (MTD) and non-tolerated dose (NTD) of CC-93269. The expansion parts (Part B and D) will further evaluate the safety and efficacy of CC-93269 administered IV or SC at or below the MTD in selected expansion cohorts of up to approximately 20 evaluable subjects each in order to determine the Recommended Phase 2 dose (RP2D).One or more dosing regimens may be selected for cohort expansion. All treatments will be administered in 28-day cycles for up to 5 years for subjects maintaining clinical benefit, or until confirmed disease progression, unacceptable toxicity, or subject/investigator decision to withdraw.
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 CC-93269 | Experimental | Drug: CC-93269 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of multiple myeloma with relapsed and refractory disease
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Must have measurable disease as determined by the central laboratory
Key exclusion criteria (5 listed)
- Symptomatic central nervous system involvement of multiple myeloma
- Prior autologous stem cell transplant ≤ 3 months prior
- Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 12 months prior
- History of concurrent second cancers requiring active, ongoing systemic treatment
- 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 |
|---|---|---|
| CC-93269Also: AlnuctamabSpecified dose on specified days | Drug | Administration of CC-93269 |
Primary outcome
Adverse Events (AEs)
Time frame: Up to approximately 63 months
Number of participants with Adverse Events
Dose Limiting Toxicity (DLT)
Time frame: Up to 60 months
Is defined as any of the toxicities occurring within the DLT assessment window (Cycle 1, Days 1 to 28) except those that are clearly and incontrovertibly due to extraneous causes.
Non-Tolerated Dose (NTD)
Time frame: Up to 60 months
Is defined as a dose level at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in the DLT window.
Maximum Tolerated Dose (MTD)
Time frame: Up to 60 months
Is defined as the last dose cohort below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during the DLT window.
14 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 60 months
Time to Response
Time frame: Up to 60 months
Duration of Response
Time frame: Up to 60 months
Progression Free Survival
Time frame: Up to 60 months
Overall Survival
Time frame: Up to 60 months
Pharmacokinetics - Cmax
Time frame: Up to 60 months
Pharmacokinetics - Cmin
Time frame: Up to 60 months
Pharmacokinetics - AUC
Time frame: Up to 60 months
Pharmacokinetics - tmax
Time frame: Up to 60 months
Pharmacokinetics - t1/2
Time frame: Up to 60 months
Pharmacokinetics - CL
Time frame: Up to 60 months
Pharmacokinetics - Vss
Time frame: Up to 60 months
Pharmacokinetics - accumulation index of alnuctamab
Time frame: Up to 60 months
Presence and frequency of anti-drug antibodies (ADA)
Time frame: Up to 60 months
Results and safety
The study was stopped early (reason given: Business objectives have changed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
34 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CC-93269 in people with Multiple Myeloma, run by Celgene at 34 sites in 6 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 3 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: stopped early, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Spain, Germany, Japan, Sweden and 1 more country. 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?
The study was stopped early (reason given: Business objectives have changed). Results are not available in the source record.
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?
Adverse Events (AEs) (time frame: Up to approximately 63 months). The study lists 4 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 17 Apr 2025.