A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus

Inclusion Criteria:

• Participants must have a diagnosis of SLE according to the 2019 European LeagueAgainst Rheumatism (EULAR) or American College of Rheumatology (ACR) ClassificationCriteria at least 24 weeks prior to Screening and should have been treated for SLEaccording to standard clinical practice.

• Presence of anti-double stranded DNA (dsDNA), anti-Smith (Sm),anti-ribonucleoprotein (RNP) or anti-Sjögren's syndrome antigen A (SS-A) above theupper limit of normal (ULN); or, positive anti-nuclear antibody (ANA; ≥ 1:160).

• Active SLE disease, as demonstrated by the Systemic Lupus Erythematosus DiseaseActivity Index 2000 (SLEDAI-2K) total score of ≥4 with at least 1 positive clinicalitem.

• For participants receiving oral corticosteroids (OCS), treatment with ≤ 20 milligramper day (mg/day) prednisone or equivalent, during Screening, at a dose that has beenstable for at least 7 days prior to Day 1.

• For participants receiving conventional immunosuppressants (e.g., azathioprine,sulfasalazine, mycophenolate mofetil [≤ 3.0 grams per day], mycophenolic acid [≤ 3grams per day], methotrexate [oral, SC, or intramuscular routes]), and calcineurininhibitors [oral]), treatment should be at a stable dose for at least 6 weeks priorto Screening and during Screening and expected to remain stable during the study.

Exclusion Criteria:

• Active or unstable lupus-associated neuropsychiatric disease.

• Catastrophic or severe antiphospholipid syndrome within 12 months prior to Screeningor during Screening.

• Presence of severe lupus-associated renal disease that is likely to requiretreatment with cyclophosphamide, B-cell-depleting therapies, other biologic ortargeted therapies.

• Organ-threatening SLE manifestations (e.g., active myocarditis) considered to besevere by the Investigator.

• Severe active systemic autoimmune disease other than SLE.

• Active infection of any kind, excluding fungal infection of the nail beds.

• History of serious recurrent or chronic infection, especially; recurring, chronicinfections specifically related to respiratory issues.

• Moderate or severe chronic obstructive pulmonary disease (COPD).

• History of progressive multifocal leukoencephalopathy (PML).

• History of macrophage-activation syndrome and/or hemophagocytic lymphohistiocytosis.

• History of cancer, including solid tumors, hematological malignancies, and carcinomain situ, within the 5 years prior to the Screening visit (with the exception ofbasal cell carcinoma, non melanoma skin cancer, and cervical cancer in situ, ifthese have been adequately treated and are considered cured).

• Intolerance or contraindication to study therapies including history of severeallergic or anaphylactic reactions to monoclonal antibodies (mAbs) or knownhypersensitivity to any component of the RO7507062 injection.

• History of infection with hepatitis B virus (HBV), or positive serology indicativeof current or past HBV infection.

• Human immunodeficiency virus (HIV; positive HIV antibody test) and active hepatitisC virus (HCV) infection (detectable HCV ribonucleic acid [RNA]).

• Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection.

• Receipt of any anti- cluster of differentiation (CD)19 or anti-CD20 therapy such asblinatumomab, obinutuzumab, rituximab, ocrelizumab, or ofatumumab less than 6 monthsprior to screening or during screening.

• Receipt of Inhibitors of Janus kinase (JAK), Bruton tyrosine kinase, or tyrosinekinase 2 including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib,and fenebrutinib,or any investigational agent within 30 days prior to screening orduring screening.

• Receipt of Cyclophosphamide or a biologic therapy such as, but not limited to,adalimumab, etanercept, golimumab, infliximab, belimumab,ustekinumab, anifrolumab,secukinumab, or atacicept, within 4 weeks prior to enrollment.

• Active tuberculosis or history of recurring or severe active tuberculosis, or apositive Interferon Gamma Release Assay (IGRA). Latent tuberculosis which has beentreated prior to baseline is not exclusive.

• Receipt of an investigational therapy (except severe acute respiratory syndromecoronavirus 2 [SARS-CoV-2] vaccines) within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment and during the study.

• Immunoglobulin (IgG) level of <6 gram per liter (g/L).

• Estimated glomerular filtration rate (eGFR) <45 milliliter per minute (mL/min)/1.73-meter square (m^2).