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Recruiting NCT07629583

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

Phase I Interventional Lupus Erythematosus, Systemic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cevostamab, Tocilizumab.
Who it may be relevant to
Registry conditions: Lupus Erythematosus, Systemic. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug Cevostamab
    Participants will receive cevostamab IV as per the schedule given in the protocol.
  • Drug Tocilizumab
    Tocilizumab may be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.

Primary outcome measures

  • Percentage of Participants with Adverse Events (AEs) [Time frame: Up to approximately 52 weeks]
Secondary outcome measures (7)
  • Serum Concentration of Cevostamab [Time frame: Up to approximately 52 weeks]
  • Area Under the Concentration-Time Curve (AUC) of Cevostamab [Time frame: Up to approximately 52 weeks]
  • Maximum Observed Serum Concentration (Cmax) of Cevostamab [Time frame: Up to approximately 52 weeks]
  • Minimum Observed Serum Concentration (Cmin) of Cevostamab [Time frame: Up to approximately 52 weeks]
  • Clearance (CL) of Cevostamab [Time frame: Up to approximately 52 weeks]
  • Volume of Distribution at Steady State (Vdss) of Cevostamab [Time frame: Up to approximately 52 weeks]
  • Change from Baseline in the Presence Anti-Drug Antibodies (ADAs) [Time frame: Up to approximately 52 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Hospital Universitario Virgen Macarena — Seville

Identifiers

NCT: NCT07629583 · GA46280 · 2025-522904-26-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗