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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03486067
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : August 20, 2021
Information provided by (Responsible Party):

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
Multiple Myeloma Drug: CC-93269 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 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 : April 3, 2018
Estimated Primary Completion Date : October 1, 2026
Estimated Study Completion Date : November 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

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 identifier (NCT number): NCT03486067

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

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Sponsors and Collaborators
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Study Director: Michael R Burgess, MD, PhD Celgene
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Responsible Party: Celgene Identifier: NCT03486067    
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: August 20, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Multiple Myeloma
Relapsed and Refractory
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases