To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis

November 4, 2026 updated by: Genentech, Inc.

An Open-Label, Multicenter, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cevostamab in Patients With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis

The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of cevostamab in participants with systemic lupus erythematosus (SLE) with or without active lupus nephritis (LN).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Recruiting
        • Royal Melbourne Hospital
  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90560-032
        • Recruiting
        • Hospital Moinhos de Vento
      • Porto Alegre, Rio Grande do Sul, Brazil, 90630-165
        • Recruiting
        • Hospital de Clnicas de Porto Alegre
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14015-010
        • Recruiting
        • Hospital das Clínicas FMRP-USP
      • Sao Jose Rio Preto, São Paulo, Brazil, 15090-000
        • Recruiting
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Recruiting
        • Peking University First Hospital
      • Beijing, Beijing Municipality, China, 100044
        • Recruiting
        • Peking University People's Hospital
    • Jiangxi
      • Pingxiang, Jiangxi, China, 337055
        • Recruiting
        • Pingxiang People's Hospital
  • France
    • Haute Garonne
      • Toulouse, Haute Garonne, France, 31059
        • Recruiting
        • Hopital Rangueil
  • Italy
    • Lombardy
      • Rozzano, Lombardy, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas
  • Spain
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria at least 6 months prior to the first screening visit
  • Active biopsy-proven LN established within 9 months of screening, demonstrating LN per 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria
  • Diagnosis of active SLE disease, as demonstrated by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
  • Inadequate response or intolerance to, in the investigator's judgement, standard of care regimens for active SLE with or without LN

Exclusion Criteria:

  • Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required
  • Treatment with investigational or non-investigational biologic therapies that directly deplete B cells (e.g., anti-CD20 or anti-CD19 monoclonal antibodies) (or blinded comparators) is prohibited within 6 months or 5 drug elimination half-lives, whichever is longer, prior to screening and during the study
  • Treatment with investigational biologic therapies that do not directly deplete B cells (or blinded comparators) is prohibited within 90 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug and during the study
  • Treatment of SLE/LN with non-investigational biologic therapies that do not directly deplete B cells (e.g., belimumab, anifrolumab) is prohibited within 4 weeks prior to screening and during the study
  • Treatment with CYC within 3 months prior to screening or during the study
  • History of known or suspected allergic reaction or anaphylactic reaction to cevostamab or its excipients
  • Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening, or any planned surgery or procedure requiring hospitalization during the 12 weeks following study drug administration
  • Alcohol or substance abuse within the 12 months prior to screening
  • Active infection of any kind, excluding fungal infection of the nail beds
  • History of serious recurrent or chronic infection
  • Tuberculosis (TB) infection
  • Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within the 12 months prior to screening or during screening
  • Catastrophic or severe antiphospholipid syndrome within the 12 months prior to screening or during screening
  • High risk for clinically significant bleeding or any condition requiring plasmapheresis, IV immunoglobulin, or acute blood product transfusions
  • Active severe or unstable lupus-associated neuropsychiatric disease, which, in the opinion of the investigator, is likely to require treatment with protocol-prohibited therapies
  • Non-SLE related CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation and Expansion

The study consists of a dose-escalation stage followed by an expansion stage. Participants in both stages will receive Cevostamab in a step-up dosing regimen, followed by a target dose.
Drug: Cevostamab

Participants will receive cevostamab IV as per the schedule given in the protocol.

Other Names:
  • RO7187797
Drug: Tocilizumab

Tocilizumab may be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.

Other Names:
  • Actemra/RoActemra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Adverse Events (AEs)
Time Frame: Up to approximately 52 weeks
Up to approximately 52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum Concentration of Cevostamab
Time Frame: Up to approximately 52 weeks
Up to approximately 52 weeks
Area Under the Concentration-Time Curve (AUC) of Cevostamab
Time Frame: Up to approximately 52 weeks
Up to approximately 52 weeks
Maximum Observed Serum Concentration (Cmax) of Cevostamab
Time Frame: Up to approximately 52 weeks
Up to approximately 52 weeks
Minimum Observed Serum Concentration (Cmin) of Cevostamab
Time Frame: Up to approximately 52 weeks
Up to approximately 52 weeks
Clearance (CL) of Cevostamab
Time Frame: Up to approximately 52 weeks
Up to approximately 52 weeks
Volume of Distribution at Steady State (Vdss) of Cevostamab
Time Frame: Up to approximately 52 weeks
Up to approximately 52 weeks
Change from Baseline in the Presence Anti-Drug Antibodies (ADAs)
Time Frame: Up to approximately 52 weeks
Up to approximately 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2026

Primary Completion (Estimated)

March 29, 2030

Study Completion (Estimated)

March 29, 2030

Study Registration Dates

First Submitted

June 1, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

November 5, 2026

Last Update Submitted That Met QC Criteria

November 4, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA46280
  • 2025-522904-26-00 (Ctis)
  • 2025 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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