Cevostamab in systemic lupus erythematosus with or without active lupus nephritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional study evaluating cevostamab, with possibly tocilizumab, in adults with systemic lupus erythematosus and active lupus nephritis or SLE without nephritis. It will assess safety, tolerability, pharmacokinetics, and pharmacodynamics to understand how the drug behaves in the body and its biological effects. Eligible participants must have established SLE, biopsy-proven active LN within 9 months, active disease by SLEDAI-2K, and insufficient response or intolerance to standard therapies. Pregnant individuals or those on certain biologic B-cell–depleting therapies are excluded. The study is led by Genentech and is being conducted at sites in Australia and Brazil.

Why it matters

Who can join: the full rules

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

Where it's running

• Royal Melbourne Hospital
  Parkville, Victoria, Australia Recruiting
• Hospital Moinhos de Vento
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting
• Hospital de Clnicas de Porto Alegre
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting
• Hospital das Clínicas FMRP-USP
  Ribeirão Preto, São Paulo, Brazil Recruiting
• Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
  Sao Jose Rio Preto, São Paulo, Brazil Recruiting
• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: GA46280 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.