| Eligibility |
Inclusion Criteria:
- Diagnosis of SLE according to the 2019 European League Against Rheumatism/American
College of Rheumatology Classification Criteria at least 12 weeks or more prior to
screening
- Presence of one or more of the following SLE autoantibodies documented within the 12
months prior to screening or during screening: positive ANA (greater than or equal to
1:160); anti dsDNA above the upper limit of normal (ULN); anti-Sm above the ULN
- Active SLE disease, as demonstrated by a SLEDAI-2K total score of greater than or
equal to 4 at screening
- Current receipt of one or more of the following classes of standard therapies for the
treatment of SLE at stable doses: oral corticosteroids (OCSs), antimalarial agents,
conventional immunosuppressants
- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraception as defined by the protocol
- For men on mycophenolate mofetil (MMF): With a female partner of childbearing
potential, men who are not surgically sterile must remain abstinent (refrain from
heterosexual intercourse) or use contraception as defined by the protocol
Exclusion Criteria:
- Pregnant or breastfeeding, or intending to become pregnant during the study or within
3 months after the final dose of mosunetuzumab and 3 months after the final dose of
tocilizumab
- Active severe or unstable lupus-associated neuropsychiatric disease that is likely to
require treatment with protocol-prohibited therapies
- Active overlap syndrome with mixed connective tissue disease or systemic sclerosis
within 12 months prior to screening or during screening
- Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening
or during screening
- Presence of significant lupus-associated renal disease and/or renal impairment that is
likely to require treatment with protocol-prohibited therapies
- Peripheral CD19+ B-cell count < 25 cells/uL
- Receipt of an investigational therapy within 30 days or 5 drug-elimination half-lives
(whichever is longer) prior to initiation of study treatment and during the study
- Receipt of any of the following excluded therapies: any anti-CD19 or anti-CD20 therapy
such as blinatumomab, obinutuzumab, rituxumab, ocrelizumab, or ofatumumab less than 12
months prior to screening or during screening; inhibitors of JAK, Bruton tyrosine
kinase, or tyrosine kinase 2, including baricitinib, tofacitinib, upadacitinib,
filgotinib, ibrutinib, or fenebrutinib, or any investigational agent within 30 days
prior to screening or during screening; tacrolimus, ciclosporin, or voclosporin within
30 day prior to screening or during screening; cyclophosphamide or a biologic therapy
such as but not limited to belimumab, ustekinumab, anifrolumab, secukinumab, or
atacicept during 2 months prior to screening or during screening; any live or
attenuated vaccine during 28 days prior to screening or during screening
- High risk for any clinically significant bleeding or any condition requiring
plasmapheresis, IV immunoglobulin, or acute blood product transfusions
- Significant or uncontrolled medical disease that would preclude participation
- HIV infection, acute or chronic hepatitis B virus (HBV), acute or chronic hepatitis C
(HCV) infection, tuberculosis (TB) infection, known or suspected chronic active
Epstein-Barr virus (EBV) infection, or cytomegalovirus (CMV) infection
- Active infection of any kind, excluding fungal infection of the nail beds
- Any major episode of infection that fulfills any of the following criteria: requires
hospitalization during 8 weeks prior to screening or during screening; requires
treatment with IV antibiotics (or anti-infective medications) during 8 weeks prior to
screening or during screening; requires treatment with oral antibiotics (or
anti-infective medications) during 2 weeks prior to screening or during screening
- History of serious recurrent or chronic infection
- History of progressive multifocal leukoencephalopathy (PML)
- History of cancer, including solid tumors, hematological malignancies, and carcinoma
in situ, within the past 5 years
- Major surgery requiring hospitalization during 4 weeks prior to screening or during
screening or any planned surgery or procedure requiring hospitalization during 12
weeks following study drug administration
- Current alcohol or drug abuse or history of alcohol or drug abuse within 12 months
prior to screening or during screening
- Intolerance or contraindication to study therapies including history of severe
allergic or anaphylactic reactions to monoclonal antibodies or known hypersensitivity
to any component of mosunetuzumab injection
- Positive serum human chorionic gonadotropin measures at screening
- Any of the following laboratory parameters: aspartate transaminase (AST) or alanine
transaminase (ALT) > 2.5 x upper limit of normal (ULN); total bilirubin > 1.5 x ULN;
absolute neutrophil count (ANC) < 2.0 x 10^9/L (< 2000/mm^3); platelet count < 100 x
10^9/L (100,000 mm^3); hemoglobin < 100 g/L (10 g/dL); estimated glomerular filtration
rate (eGFR) < 30 ml/min/1.73 m^2 calculated according to the Chronic Kidney Disease
Epidemiology Collaboration equation; positive serum human chorionic gonadotropin
measured at screening
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