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Clinical Trials in Spain / NCT07629583
Recruiting Phase 1

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

NCT07629583 · tracked via the Priya Life Science Spain tracker
Phase
Phase 1
Started
2026-10-31
Last updated
2026-09-08

Condition(s) studied

Lupus Erythematosus, Systemic

Investigational drug(s) / intervention(s)

Cevostamab →Tocilizumab →

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

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

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital Universitario Virgen Macarena Seville Spain Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07629583 on ClinicalTrials.gov ↗ ← All trials in Spain