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

  • Clinicaltrials.gov identifier

    NCT03486067

  • Recruitment Status

    Recruiting

  • First Posted

    April 3, 2018

  • Last update posted

    May 28, 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
CC-93269

Outcome Measures

  • Primary Outcome Measures: 1. Adverse Events (AEs) [ Time Frame: Up to 48 months ]
    Number of participants with Adverse Events
  • 2. 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.
  • 3. 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.
  • 4. 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.
  • 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

Criteria

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

Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@bms.com

Locations

United States, Alabama
University of Alabama at Birmingham
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
Atlanta

United States, Massachusetts
Massachusetts General Hospital
Boston

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston

United States, Massachusetts
Dana Farber Cancer Institute
Boston

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

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

United States, Washington
Swedish Cancer Institute
Seattle

Germany
Universitaetsklinik Hamburg - Eppendorf
Hamburg

Germany
Universitaetsklinikum Heidelberg
Heidelberg

Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo

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

Italy
Istituto Clinico Humanitas
Milan

Spain
Hospital Universitari Germans Trias i Pujol ICO Badalona
Barcelona

Spain
Hospital General Gregorio Maranon
Madrid

Spain
Clinica Universidad de Navarra
Pamplona

Spain
Hospital Universitario de Salamanca
Salamanca

Spain
Hospital Universtario Marques de Valdecilla
Santander

Spain
Hospital Universitario Doctor Peset
Valencia

Sweden
Skanes Universitetssjukhus Lund
Lund

Sweden
Karolinska Universitetssjukhuset - Solna
Solna

Sponsors and Collaborators

Celgene

Investigators

Study Director: Michael R Burgess, MD, PhD Celgene

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov 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: May 28, 2021
  • Last Verified: May 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: Multiple Myeloma
    BCMA X CD3 T Cell
    Antibody
    CC-93269
    Relapsed and Refractory
  • Additional relevant MeSH terms: Multiple Myeloma Neoplasms, Plasma Cell