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

Sponsor
Celgene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03486067
Collaborator
(none)
220
Enrollment
28
Locations
1
Arm
112.9
Anticipated Duration (Months)
7.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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 Intervention/Treatment 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
Anticipated Enrollment :
220 participants
Allocation:
N/A
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 :
Apr 3, 2018
Anticipated Primary Completion Date :
Jul 26, 2027
Anticipated Study Completion Date :
Aug 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Administration of CC-93269

Drug: CC-93269
Specified dose on specified days
Other Names:
  • Alnuctamab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse Events (AEs) [Up to 60 months]

      Number of participants with Adverse Events

    2. Dose Limiting Toxicity (DLT) [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) [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) [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) [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 [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 [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 [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 [Up to 60 months]

      Is defined as the time from the first dose of CC-93269 to death from any cause.

    6. Pharmacokinetics - Cmax [Up to 60 months]

      Maximum serum concentration of drug

    7. Pharmacokinetics - Cmin [Up to 60 months]

      Minimum serum concentration of drug

    8. Pharmacokinetics - AUC [Up to 60 months]

      Area under the curve

    9. Pharmacokinetics - tmax [Up to 60 months]

      Time to peak (maximum) serum concentration

    10. Pharmacokinetics - t1/2 [Up to 60 months]

      Terminal Half-life

    11. Pharmacokinetics - CL [Up to 60 months]

      Apparent total body clearance

    12. Pharmacokinetics - Vss [Up to 60 months]

      Volume of distribution at steady-state

    13. Pharmacokinetics - accumulation index of alnuctamab [Up to 60 months]

      Accumulation ratio of drug

    14. Presence and frequency of anti-drug antibodies (ADA) [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 [Up to 60 months]

      Measurement of tumor and immune factors

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 University of California San Francisco Medical Center San Francisco California United States 94142
    3 Yale Cancer Center New Haven Connecticut United States 06510
    4 Winship Cancer Institute of Emory University Atlanta Georgia United States 30322
    5 Massachusetts General Hospital Boston Massachusetts United States 02114
    6 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    7 Henry Ford Medical Center - New Center One Detroit Michigan United States 48202
    8 Icahn School of Medicine at Mount Sinai Mount Sinai West New York New York United States 10019
    9 Swedish Cancer Institute Seattle Washington United States 98104
    10 Universitatsklinikum Erlangen Erlangen Germany 91054
    11 Universitaetsklinik Hamburg - Eppendorf Hamburg Germany 20246
    12 Universitaetsklinikum Heidelberg Heidelberg Germany 69120
    13 University of Tubingen Tuebingen Germany 72076
    14 Azienda Ospedaliera Papa Giovanni XXIII Bergamo Italy 24127
    15 Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.) Meldola Italy 47014
    16 Istituto Clinico Humanitas Milan Italy 20089
    17 Vall d´Hebron University Hospital Barcelona Spain 08035
    18 Hospital Universitari Germans Trias i Pujol ICO Badalona Barcelona Spain 08916
    19 Hospital General Gregorio Maranon Madrid Spain 28007
    20 Clinica Universidad de Navarra Pamplona Spain 31008
    21 Hospital Universitario de Salamanca Salamanca Spain 37007
    22 Hospital Universtario Marques de Valdecilla Santander Spain 39008
    23 Hospital de la Fe Valencia Spain 46009
    24 Hospital Universitario Doctor Peset Valencia Spain 46017
    25 Sahlgrenska University Hospital Gothenborg Sweden 413 46
    26 Skanes Universitetssjukhus Lund Lund Sweden SE-221 85
    27 Karolinska Universitetssjukhuset - Solna Solna Sweden 171 76
    28 Akademiska Hospital Uppsala Uppsala Sweden 75158

    Sponsors and Collaborators

    • Celgene

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Celgene
    ClinicalTrials.gov Identifier:
    NCT03486067
    Other Study ID Numbers:
    • CC-93269-MM-001
    • U1111-1210-6325
    • 2017-003448-19
    First Posted:
    Apr 3, 2018
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 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

    Study Results

    No Results Posted as of Aug 3, 2022