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

  • Clinicaltrials.gov identifier

    NCT03486067

  • Recruitment Status

    Recruiting

  • First Posted

    April 3, 2018

  • Last update posted

    April 28, 2022

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: 220 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma
  • Actual Study Start Date: April 2018
  • Estimated Primary Completion Date: July 2027
  • Estimated Study Completion Date: August 2027

Arms and interventions

Arm Intervention/treatment
Experimental: Administration of CC-93269
Drug: CC-93269
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Adverse Events (AEs) [ Time Frame: Up to 60 months ]
    Number of participants with Adverse Events
  • 2. 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.
  • 3. 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.
  • 4. 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.
  • Secondary Outcome Measures: 1. 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.
  • 2. 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).
  • 3. 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.
  • 4. 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.
  • 5. 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.
  • 6. Pharmacokinetics - Cmax [ Time Frame: Up to 60 months ]
    Maximum serum concentration of drug
  • 7. Pharmacokinetics - Cmin [ Time Frame: Up to 60 months ]
    Minimum serum concentration of drug
  • 8. Pharmacokinetics - AUC [ Time Frame: Up to 60 months ]
    Area under the curve
  • 9. Pharmacokinetics - tmax [ Time Frame: Up to 60 months ]
    Time to peak (maximum) serum concentration
  • 10. Pharmacokinetics - t1/2 [ Time Frame: Up to 60 months ]
    Terminal Half-life
  • 11. Pharmacokinetics - CL [ Time Frame: Up to 60 months ]
    Apparent total body clearance
  • 12. Pharmacokinetics - Vss [ Time Frame: Up to 60 months ]
    Volume of distribution at steady-state
  • 13. Pharmacokinetics - accumulation index of alnuctamab [ Time Frame: Up to 60 months ]
    Accumulation ratio of drug
  • 14. 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
  • 15. Evaluate measures of tumor sensitivity/ resistance to CC-93269 [ Time Frame: Up to 60 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: 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

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

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

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham

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, 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
Universitatsklinikum Erlangen
Erlangen

Germany
Universitaetsklinik Hamburg - Eppendorf
Hamburg

Germany
Universitaetsklinikum Heidelberg
Heidelberg

Germany
University of Tubingen
Tuebingen

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
Vall d´Hebron University Hospital
Barcelona

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 de la Fe
Valencia

Spain
Hospital Universitario Doctor Peset
Valencia

Sweden
Sahlgrenska University Hospital
Gothenborg

Sweden
Skanes Universitetssjukhus Lund
Lund

Sweden
Karolinska Universitetssjukhuset - Solna
Solna

Sweden
Akademiska Hospital Uppsala
Uppsala

Sponsors and Collaborators

Celgene

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

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: April 28, 2022
  • Last Verified: April 2022
  • 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
    Neoplasms by Histologic Type
    Neoplasms
    Hemostatic Disorders
    Vascular Diseases
    Cardiovascular Diseases
    Paraproteinemias
    Blood Protein Disorders
    Hematologic Diseases
    Hemorrhagic Disorders
    Lymphoproliferative Disorders
    Immunoproliferative Disorders
    Immune System Diseases