This website is for US healthcare professionals


Log In to Bolder Science


Don't have an account? Sign Up


Please enter your email address.

You will receive a link to create a new password via email.

Log In


Create an Account

  • 8 characters minimum
  • First character may not be a number
  • Last character may not be a number

Welcome and thank you for creating an account!

At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

Condition Categories

Condition categories are pulled directly from Choose 1 or more condition categories that you are interested in:

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

Set a default location

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

  • identifier


  • Recruitment Status


  • First Posted

    April 3, 2018

  • Last update posted

    October 6, 2021

Study Description

Brief 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.

  • Condition or Disease:Multiple Myeloma
  • Intervention/Treatment: Drug: CC-93269
  • Phase: Phase 1

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 2 years or extended up to 5 years for subjects maintaining clinical benefit at the discretion of the Safety Review Committee, until confirmed disease progression, unacceptable toxicity, or subject/investigator decision to withdraw.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 175 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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.
  • Actual Study Start Date: April 2018
  • Estimated Primary Completion Date: October 2026
  • Estimated Study Completion Date: November 2026

Arms and interventions

Arm Intervention/treatment
Experimental: Administration of CC-93269
CC-93269 will be administered to each patient on a 28-day cycle
Drug: CC-93269

Outcome Measures

  • Primary Outcome Measures: 1. Maximum Tolerated Dose (MTD) [ Time Frame: Up to 48 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.
  • 2. Adverse Events (AEs) [ Time Frame: Up to 48 months ]
    Number of participants with Adverse Events
  • 3. Dose Limiting Toxicity (DLT) [ Time Frame: Up to 48 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.
  • 4. Non-Tolerated Dose (NTD) [ Time Frame: Up to 48 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.
  • Secondary Outcome Measures: 1. Overall Response Rate (ORR) [ Time Frame: Up to 48 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.
  • 2. Time to Response [ Time Frame: Up to 48 months ]
    Is defined as the time from the first CC-93269 dose date to the date of first documented response (PR or better).
  • 3. Duration of Response [ Time Frame: Up to 48 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.
  • 4. Progression Free Survival [ Time Frame: Up to 48 months ]
    Is defined as the time from the first dose of CC-93269 to progressive disease or death from any cause, whichever occurs first.
  • 5. Overall Survival [ Time Frame: Up to 48 months ]
    Is defined as the time from the first dose of CC-93269 to death from any cause.
  • 6. Pharmacokinetics - Cmax [ Time Frame: Up to 48 months ]
    Maximum serum concentration of drug
  • 7. Pharmacokinetics - Cmin [ Time Frame: Up to 48 months ]
    Minimum serum concentration of drug
  • 8. Pharmacokinetics - AUC [ Time Frame: Up to 48 months ]
    Area under the curve
  • 9. Pharmacokinetics - tmax [ Time Frame: Up to 48 months ]
    Time to peak (maximum) serum concentration
  • 10. Pharmacokinetics - t1/2 [ Time Frame: Up to 48 months ]
    Terminal Half-life
  • 11. Pharmacokinetics - CL [ Time Frame: Up to 48 months ]
    Apparent total body clearance
  • 12. Pharmacokinetics - Vss [ Time Frame: Up to 48 months ]
    Volume of distribution at steady-state
  • 13. Pharmacokinetics - accumulation index of CC-93269 [ Time Frame: Up to 48 months ]
    Accumulation ratio of drug
  • 14. Presence and frequency of anti-drug antibodies (ADA) [ Time Frame: Up to 48 months ]
    Detection of anti-drug antibodies in participants and frequency of anti-drug antibodies
  • 15. Evaluate measures of tumor sensitivity/ resistance to CC-93269 [ Time Frame: Up to 48 months ]
    Measurement of tumor and immune factors

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No


Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted. 2. Subject (male or female) is ≥ 18 years of age the time of signing the ICF. 3. Subject has non-secretory multiple myeloma, plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) syndrome, or amyloidosis. 4. Subjects must have measurable disease (as determined by the central lab). 5. Subject consents to hospitalization for monitoring and collection of study peripheral blood samples. 6. Subject consents to serial bone marrow aspirations and/or biopsies during Screening, study treatment and at the end of treatment. 7. Subject has an Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1. 8. Subjects must have adequate hematologic, liver, renal, and coagulation function as assessed by laboratory tests. 9. Females and males must practice true abstinence or agree to contraceptive methods throughout the study, and during the safety follow-up period. Exclusion Criteria: The presence of any of the following will exclude a subject from enrollment: 1. Subject has received prior therapy directed at B cell maturation antigen (BCMA). 2. Subject has symptomatic central nervous system involvement of multiple myeloma. 3. Subject has non-secretory multiple myeloma, plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis. 4. Subject is on chronic systemic immunosuppressive therapy or corticosteroids. 5. Subjects with clinically significant cardiac disease. 6. Subject had a prior autologous stem cell transplant ≤ 3 month prior to starting CC-93269. 7. Subject had a prior allogeneic stem cell transplant ≤ 12 month prior to starting CC-93269. 8. Subject had a prior systemic cancer-directed treatments or investigational modalities ≤ 5 half-lives or 4 weeks prior to starting CC-93269, whichever is shorter. Subjects must have recovered from any clinically significant non-hematologic toxicities (ie, to Grade ≤1) of prior systemic anti-cancer directed treatments unless otherwise specified 9. Subject had major surgery ≤ 2 weeks prior to starting CC-93269. 10. Subject is a pregnant or lactating female. 11. Subject has known history or serologic evidence of human immunodeficiency virus (HIV) infection. 12. Subject has known history, virologic or serological evidence of hepatitis B or C virus (HBV/HCV) infection. Subjects who had HCV but have received an antiviral treatment and show no detectable HCV viral RNA for 6 months are eligible 13. Subject has a history of a venous thromboembolic event (VTE) within 6 months prior to study entry (eg, deep-vein thrombosis or pulmonary embolism). Subjects with distant history of VTE (ie, occurring > 6 months prior to study entry) who require ongoing treatment with chronic, therapeutic dosing of anti-coagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors) are eligible for study entry. 14. Subject has a history of concurrent second cancers requiring active, ongoing systemic treatment. 15. Subject has a history or presence of clinically relevant central nervous system (CNS) pathology. 16. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 17. Subject has any condition (eg, active or uncontrolled infection) including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. . 18. Subject has any condition that confounds the ability to interpret data from the study. 19. Subject has inadequate pulmonary function. 20. Subject has active, uncontrolled, or suspected infection. 21. Subject has pulmonary, cardiac, or hepatic involvement of extramedullary multiple myeloma. 22. Subjects with a history of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product. 23. Recent SARS-CoV-2 vaccine as specified in the protocol.

Contacts and Locations


Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599


United States, Alabama
University of Alabama at Birmingham

United States, California
University of California San Francisco Medical Center
San Francisco

United States, Connecticut
Yale Cancer Center
New Haven

United States, Georgia
Winship Cancer Institute of Emory University

United States, Massachusetts
Massachusetts General Hospital

United States, Massachusetts
Beth Israel Deaconess Medical Center

United States, Massachusetts
Dana Farber Cancer Institute

United States, Michigan
Henry Ford Medical Center - New Center One

United States, New York
Icahn School of Medicine at Mount Sinai Mount Sinai West
New York

United States, Washington
Swedish Cancer Institute

Universitaetsklinik Hamburg - Eppendorf

Universitaetsklinikum Heidelberg

Azienda Ospedaliera Papa Giovanni XXIII

Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

Istituto Clinico Humanitas

Vall d´Hebron University Hospital

Hospital Universitari Germans Trias i Pujol ICO Badalona

Hospital General Gregorio Maranon

Clinica Universidad de Navarra

Hospital Universitario de Salamanca

Hospital Universtario Marques de Valdecilla

Hospital de la Fe

Hospital Universitario Doctor Peset

Sahlgrenska University Hospital

Skanes Universitetssjukhus Lund

Karolinska Universitetssjukhuset - Solna

Sponsors and Collaborators



Study Director: Michael R Burgess, MD, PhD Celgene

More Information

  • Responsible Party: Celgene
  • Identifier: NCT03486067 History of Changes
  • Other Study ID Numbers: CC-93269-MM-001, U1111-1210-6325, 2017-003448-19
  • First Posted: April 3, 2018 Key Record Dates
  • Last Update Posted: October 6, 2021
  • Last Verified: October 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: Relapsed and Refractory
    BCMA X CD3 T Cell
    Multiple Myeloma
  • Additional relevant MeSH terms: Neoplasms, Plasma Cell Multiple Myeloma