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

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ClinicalTrials.gov Identifier: NCT03486067
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: CC-93269 Phase 1

Detailed Description:
The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-93269, administered intravenously (IV), to determine the maximum tolerated dose (MTD) and non-tolerated dose (NTD) of both the first dose and subsequent doses of CC-93269. The expansion part (Part B) will further evaluate the safety and efficacy of CC-93269 administered at or below the MTD in selected expansion cohorts 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 until confirmed disease progression, unacceptable toxicity, or subject/Investigator decision to withdraw.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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 3, 2018
Estimated Primary Completion Date : July 26, 2021
Estimated Study Completion Date : June 16, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Administration of CC-93269
CC-93269 by intravenous (IV) infusion on a 28 day cycle.
Drug: CC-93269
CC-93269




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



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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 a history of Multiple Myeloma (MM) with relapsed and refractory disease, and must have failed treatment with, are intolerant to or are not candidates for available therapies that are known to confer clinical benefit to patients with relapsed and refractory MM.
  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 (Part A only).
  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 investigational 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.
  9. Subject had major surgery ≤ 2 weeks prior to starting CC-93269.
  10. Subject is a pregnant or lactating female.
  11. Subject has known human immunodeficiency virus (HIV) infection.
  12. Subject has known history or serological evidence of prior hepatitis B or C virus (HBV/HCV) infection.
  13. Subject requires ongoing treatment with chronic, therapeutic dosing of anti-coagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors)
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486067


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

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
United States, California
UCSF Medical Center Recruiting
San Francisco, California, United States, 94143
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Germany
Universitatsklinikum Heidelberg Medizinische Klinik Krehl-Klinik Haematologie, Onkologie, Rheumato Not yet recruiting
Heidelberg, Germany, 69120
University of Tubingen Not yet recruiting
Tübingen, Germany, 72076
Spain
Clinica Universitaria de Navarra Recruiting
Pamplona, Spain, 31008
Hospital Universitario de Salamanca Recruiting
Salamanca, Spain, 37007
Hospital Universtario Marques de Valdecilla Recruiting
Santander, Spain, 39008
Hospital Universitario Doctor Peset Recruiting
Valencia, Spain, 46017
Sponsors and Collaborators
Celgene
Investigators
Study Director: Michael R Burgess, MD, PhD Celgene

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03486067     History of Changes
Other Study ID Numbers: CC-93269-MM-001
U1111-1210-6325 ( Registry Identifier: WHO )
2017-003448-19 ( EudraCT Number )
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018

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
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs