Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma

April 15, 2025 updated by: Celgene

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
183

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain the NCT# and Site #.

Study Locations

  • Germany
      • Erlangen, Germany, 91054
        • Local Institution - 305
      • Hamburg, Germany, 20246
        • Local Institution - 303
      • Heidelberg, Germany, 69120
        • Local Institution - 302
      • München, Germany, 81675
        • Local Institution - 306
      • Tuebingen, Germany, 72076
        • Local Institution - 304
  • Italy
      • Bergamo, Italy, 24127
        • Local Institution - 402
      • Meldola, Italy, 47014
        • Local Institution - 403
      • Milan, Italy, 20089
        • Local Institution - 401
  • Japan
      • Kamakura, Japan, 247-8533
        • Local Institution - 605
      • Kashiwa, Japan, 277-8577
        • Local Institution - 604
      • Kyoto, Japan, 602-8566
        • Local Institution - 601
    • Aichi
      • Nagoya-shi, Aichi, Japan, 4678602
        • Local Institution - 602
    • Tokyo
      • Shibuya-ku, Tokyo, Japan, 1508935
        • Local Institution - 603
  • Spain
      • Barcelona, Spain, 08916
        • Local Institution - 206
      • Barcelona, Spain, 8035
        • Local Institution - 208
      • Madrid, Spain, 28007
        • Local Institution - 205
      • Pamplona, Spain, 31008
        • Local Institution - 201
      • Salamanca, Spain, 37007
        • Local Institution - 203
      • Santander, Spain, 39008
        • Local Institution - 204
      • Valencia, Spain, 46009
        • Local Institution - 207
      • Valencia, Spain, 46017
        • Local Institution - 202
  • Sweden
      • Gothenborg, Sweden, 413 46
        • Local Institution - 504
      • Lund, Sweden, SE-221 85
        • Local Institution - 502
      • Stockholm, Sweden, 141 86
        • Local Institution - 501
      • Uppsala, Sweden, 75158
        • Local Institution - 505
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Local Institution - 105
    • California
      • San Francisco, California, United States, 94143
        • Local Institution - 103
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Local Institution - 107
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Local Institution - 106
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 109
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 111
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Medical Center - New Center One
    • New York
      • New York, New York, United States, 10019
        • Icahn School of Medicine at Mount Sinai Mount Sinai West
    • Washington
      • Seattle, Washington, United States, 98104
        • Local Institution - 101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Administration of CC-93269
Drug: CC-93269
Specified dose on specified days
Other Names:
  • Alnuctamab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 60 months
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.
Up to 60 months
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.
Up to 60 months
Adverse Events (AEs)
Time Frame: Up to approximately 63 months
Number of participants with Adverse Events
Up to approximately 63 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics - AUC
Time Frame: Up to 60 months
Area under the curve
Up to 60 months
Overall Response Rate (ORR)
Time Frame: Up to 60 months
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.
Up to 60 months
Time to Response
Time Frame: Up to 60 months
Is defined as the time from the first CC-93269 dose date to the date of first documented response (PR or better).
Up to 60 months
Duration of Response
Time Frame: Up to 60 months
Is defined as the time from the earliest date of documented response (≥ PR) to the first documented disease progression or death, whichever occurs first.
Up to 60 months
Progression Free Survival
Time Frame: Up to 60 months
Is defined as the time from the first dose of CC-93269 to progressive disease or death from any cause, whichever occurs first.
Up to 60 months
Overall Survival
Time Frame: Up to 60 months
Is defined as the time from the first dose of CC-93269 to death from any cause.
Up to 60 months
Pharmacokinetics - Cmax
Time Frame: Up to 60 months
Maximum serum concentration of drug
Up to 60 months
Pharmacokinetics - Cmin
Time Frame: Up to 60 months
Minimum serum concentration of drug
Up to 60 months
Pharmacokinetics - tmax
Time Frame: Up to 60 months
Time to peak (maximum) serum concentration
Up to 60 months
Pharmacokinetics - t1/2
Time Frame: Up to 60 months
Terminal Half-life
Up to 60 months
Pharmacokinetics - CL
Time Frame: Up to 60 months
Apparent total body clearance
Up to 60 months
Pharmacokinetics - Vss
Time Frame: Up to 60 months
Volume of distribution at steady-state
Up to 60 months
Pharmacokinetics - accumulation index of alnuctamab
Time Frame: Up to 60 months
Accumulation ratio of drug
Up to 60 months
Presence and frequency of anti-drug antibodies (ADA)
Time Frame: Up to 60 months
Detection of anti-drug antibodies in participants and frequency of anti-drug antibodies
Up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celgene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 18, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CC-93269-MM-001
  • U1111-1210-6325 (Registry Identifier: WHO)
  • 2023-506564-14 (Other Identifier: EU CTR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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