Clinical Trials /

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

NCT03486067

Description:

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

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: CC-93269-MM-001
  • SECONDARY ID: U1111-1210-6325
  • SECONDARY ID: 2017-003448-19
  • NCT ID: NCT03486067

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
CC-93269Administration of CC-93269

Purpose

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

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 MTD and 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 IV at or below the MTD in
      selected expansion cohorts of up to approximately 20 evaluable subjects each in order to
      determine the RP2D. CC-93269, administered IV followed by subcutaneously (SC), will also be
      evaluated (Part C). 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.
    

Trial Arms

NameTypeDescriptionInterventions
Administration of CC-93269ExperimentalCC-93269 by intravenous (IV) infusion or subcutaneous (SC) injection on a 28 day cycle.
  • CC-93269

Eligibility 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.

          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. Unless otherwise specified, Subject has received prior investigational therapy
             directed at B cell maturation antigen (BCMA). In selected cohort(s) of Parts A and B,
             prior therapy directed at BCMA may be required for enrollment

          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. Inadequate pulmonary function.

         20. Subject has active, uncontrolled, or suspected infection.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Adverse Events (AEs)
Time Frame:Up to 48 months
Safety Issue:
Description:Number of participants with Adverse Events

Secondary Outcome Measures

Measure:Overall Response Rate (ORR)
Time Frame:Up to 48 months
Safety Issue:
Description: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.
Measure:Time to Response
Time Frame:Up to 48 months
Safety Issue:
Description:Is defined as the time from the first CC-93269 dose date to the date of first documented response (PR or better).
Measure:Duration of Response
Time Frame:Up to 48 months
Safety Issue:
Description:Is defined as the time from the earliest date of documented response (≥ PR) to the first documented disease progression or death, whichever occurs first.
Measure:Progression Free Survival
Time Frame:Up to 48 months
Safety Issue:
Description:Is defined as the time from the first dose of CC-93269 to progressive disease or death from any cause, whichever occurs first.
Measure:Overall Survival
Time Frame:Up to 48 months
Safety Issue:
Description:Is defined as the time from the first dose of CC-93269 to death from any cause.
Measure:Pharmacokinetics - Cmax
Time Frame:Up to 48 months
Safety Issue:
Description:Maximum serum concentration of drug
Measure:Pharmacokinetics - Cmin
Time Frame:Up to 48 months
Safety Issue:
Description:Minimum serum concentration of drug
Measure:Pharmacokinetics - AUC
Time Frame:Up to 48 months
Safety Issue:
Description:Area under the curve
Measure:Pharmacokinetics - tmax
Time Frame:Up to 48 months
Safety Issue:
Description:Time to peak (maximum) serum concentration
Measure:Pharmacokinetics - t1/2
Time Frame:Up to 48 months
Safety Issue:
Description:Terminal Half-life
Measure:Pharmacokinetics - CL
Time Frame:Up to 48 months
Safety Issue:
Description:Apparent total body clearance
Measure:Pharmacokinetics - Vss
Time Frame:Up to 48 months
Safety Issue:
Description:Volume of distribution at steady-state
Measure:Pharmacokinetics - accumulation index of CC-93269
Time Frame:Up to 48 months
Safety Issue:
Description:Accumulation ratio of drug
Measure:Presence and frequency of anti-drug antibodies (ADA)
Time Frame:Up to 48 months
Safety Issue:
Description:Detection of anti-drug antibodies in participants and frequency of anti-drug antibodies
Measure:Evaluate measures of tumor sensitivity/ resistance to CC-93269
Time Frame:Up to 48 months
Safety Issue:
Description:Measurement of tumor and immune factors

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Celgene

Trial Keywords

  • Multiple Myeloma
  • BCMA X CD3 T Cell
  • Antibody
  • CC-93269
  • Relapsed and Refractory

Last Updated

December 11, 2019