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

NCT07629583 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: GA462802025-522904-26-00
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Lupus Erythematosus, Systemic

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Adverse Events (AEs)

  Up to approximately 52 weeks

Secondary Outcomes (7)

• Serum Concentration of Cevostamab

  Up to approximately 52 weeks

• Area Under the Concentration-Time Curve (AUC) of Cevostamab

  Up to approximately 52 weeks

• Maximum Observed Serum Concentration (Cmax) of Cevostamab

  Up to approximately 52 weeks

• Minimum Observed Serum Concentration (Cmin) of Cevostamab

  Up to approximately 52 weeks

• Clearance (CL) of Cevostamab

  Up to approximately 52 weeks

Study Arms (1)

Dose Escalation and Expansion

EXPERIMENTAL

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; Drug: Tocilizumab

Interventions

Cevostamab DRUG

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

Also known as: RO7187797

Dose Escalation and Expansion

Tocilizumab DRUG

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

Also known as: Actemra/RoActemra

Dose Escalation and Expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): March 29, 2030
• Study Completion (Estimated): March 29, 2030
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share