Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Subjects With Relapsed and Refractory Multiple Myeloma
a study on Multiple Myeloma
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.
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.
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.
Multiple Myeloma BCMA X CD3 T Cell Antibody CC-93269 Relapsed and Refractory Neoplasms, Plasma Cell Administration of CC-93269
You can join if…
Open to people ages 18 years and up
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 non-secretory multiple myeloma, plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) syndrome, or amyloidosis.
- Subjects must have measurable disease (as determined by the central lab).
- Subject consents to hospitalization for monitoring and collection of study peripheral blood samples.
- 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.
You CAN'T join if...
The presence of any of the following will exclude a subject from enrollment:
- Subject has received prior 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. 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
- Subject had major surgery ≤ 2 weeks prior to starting CC-93269.
- . Subject is a pregnant or lactating female.
- . Subject has known history or serologic evidence of human immunodeficiency virus (HIV) infection.
- . 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
- . 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.
- . 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.
- . Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- . 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. .
- . Subject has any condition that confounds the ability to interpret data from the study.
- . Subject has inadequate pulmonary function.
- . Subject has active, uncontrolled, or suspected infection.
- . Subject has pulmonary, cardiac, or hepatic involvement of extramedullary multiple myeloma.
- . Subjects with a history of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.
- . Recent SARS-CoV-2 vaccine as specified in the protocol.
- University of California San Francisco Medical Center
accepting new patients
San Francisco California 94142 United States
- Swedish Cancer Institute
accepting new patients
Seattle Washington 98104 United States
Lead Scientist at UCSF
- accepting new patients
- Start Date
- Completion Date
- Phase 1
- Study Type
- Last Updated
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