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

Overview

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.

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.

SparkCures ID 947
Trial Phase Phase 1
Enrollment 120 Patients
Treatments
Trial Sponsors
  • Celgene Corporation
NCT Identifier

NCT03486067

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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.

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Henry Ford Hospital

Detroit, MI

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

Verified Winship Cancer Institute of Emory University -

SparkCures Verified Accurate, up-to-date information. Learn more


Alabama
California
Connecticut
Georgia
Verified Winship Cancer Institute of Emory University -

SparkCures Verified Accurate, up-to-date information. Learn more

Michigan
Henry Ford Hospital

Detroit, MI

Washington
International Locations

This trial has active trial locations in countries outside of the United States.

Our system currently only provides clinical trial matching services for myeloma patients in the United States.

You can view this clinical trial's international locations by visiting ClinicalTrials.gov. Please be aware that the government website may include information that is inaccurate and/or out-of-date.

Resources

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