Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Subjects With Relapsed and Refractory Multiple Myeloma
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.
March 23, 2018
Cancer (Hematology) - Multiple Myeloma / Plasma Cell Malignancies
William Bensinger, MD
Swedish Cancer Institute
|Ages Eligible for Study:
||18 Years and older (Adult, Older Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
Subjects must satisfy the following criteria to be enrolled in the study:
- Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
- Subject (male or female) is ≥ 18 years of age the time of signing the ICF.
- 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.
- Subjects must have measurable disease (as determined by the central lab).
- Subject consents to hospitalization for monitoring and collection of study peripheral blood samples (Part A only).
- Subject consents to serial bone marrow aspirations and/or biopsies during Screening, study treatment and at the end of treatment.
- Subject has an Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
- Subjects must have adequate hematologic, liver, renal, and coagulation function as assessed by laboratory tests.
- Females and males must practice true abstinence or agree to contraceptive methods throughout the study, and during the safety follow-up period.
The presence of any of the following will exclude a subject from enrollment:
- Subject has received prior investigational therapy directed at B cell maturation antigen (BCMA).
- Subject has symptomatic central nervous system involvement of multiple myeloma.
- Subject has non-secretory multiple myeloma, plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis.
- Subject is on chronic systemic immunosuppressive therapy or corticosteroids.
- Subjects with clinically significant cardiac disease.
- Subject had a prior autologous stem cell transplant ≤ 3 month prior to starting CC-93269.
- Subject had a prior allogeneic stem cell transplant ≤ 12 month prior to starting CC-93269.
- 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.
- Subject had major surgery ≤ 2 weeks prior to starting CC-93269.
- Subject is a pregnant or lactating female.
- Subject has known human immunodeficiency virus (HIV) infection.
- Subject has known history or serological evidence of prior hepatitis B or C virus (HBV/HCV) infection.
- Subject requires ongoing treatment with chronic, therapeutic dosing of anti-coagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors)
- Subject has a history of concurrent second cancers requiring active, ongoing systemic treatment.
- Subject has a history or presence of clinically relevant central nervous system (CNS) pathology.