To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
4. november 2026 oppdatert av: 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).
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
46
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Studer Kontakt Backup
- Navn: Reference Study ID Number: GA46280 https://forpatients.roche.com/ No attachments to email below.
- Telefonnummer: 888-662-6728
- E-post: global-roche-genentech-trials@gene.com
Studiesteder
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Victoria
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Parkville, Victoria, Australia, 3052
- Rekruttering
- Royal Melbourne Hospital
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90560-032
- Rekruttering
- Hospital Moinhos de Vento
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Porto Alegre, Rio Grande do Sul, Brasil, 90630-165
- Rekruttering
- Hospital de Clnicas de Porto Alegre
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São Paulo
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Ribeirão Preto, São Paulo, Brasil, 14015-010
- Rekruttering
- Hospital das Clínicas FMRP-USP
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Sao Jose Rio Preto, São Paulo, Brasil, 15090-000
- Rekruttering
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
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Haute Garonne
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Toulouse, Haute Garonne, Frankrike, 31059
- Rekruttering
- Hopital Rangueil
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Lombardy
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Rozzano, Lombardy, Italia, 20089
- Rekruttering
- Istituto Clinico Humanitas
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100034
- Rekruttering
- Peking University First Hospital
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Beijing, Beijing Municipality, Kina, 100044
- Rekruttering
- Peking University People's Hospital
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Jiangxi
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Pingxiang, Jiangxi, Kina, 337055
- Rekruttering
- Pingxiang People's Hospital
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Seville, Spania, 41009
- Rekruttering
- Hospital Universitario Virgen Macarena
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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. |
Participants will receive cevostamab IV as per the schedule given in the protocol.
Andre navn:
Tocilizumab may be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Percentage of Participants with Adverse Events (AEs)
Tidsramme: Up to approximately 52 weeks
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Up to approximately 52 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Serum Concentration of Cevostamab
Tidsramme: Up to approximately 52 weeks
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Up to approximately 52 weeks
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Area Under the Concentration-Time Curve (AUC) of Cevostamab
Tidsramme: Up to approximately 52 weeks
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Up to approximately 52 weeks
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Maximum Observed Serum Concentration (Cmax) of Cevostamab
Tidsramme: Up to approximately 52 weeks
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Up to approximately 52 weeks
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Minimum Observed Serum Concentration (Cmin) of Cevostamab
Tidsramme: Up to approximately 52 weeks
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Up to approximately 52 weeks
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Clearance (CL) of Cevostamab
Tidsramme: Up to approximately 52 weeks
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Up to approximately 52 weeks
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Volume of Distribution at Steady State (Vdss) of Cevostamab
Tidsramme: Up to approximately 52 weeks
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Up to approximately 52 weeks
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Change from Baseline in the Presence Anti-Drug Antibodies (ADAs)
Tidsramme: Up to approximately 52 weeks
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Up to approximately 52 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
2. november 2026
Primær fullføring (Antatt)
29. mars 2030
Studiet fullført (Antatt)
29. mars 2030
Datoer for studieregistrering
Først innsendt
1. juni 2026
Først innsendt som oppfylte QC-kriteriene
1. juni 2026
Først lagt ut (Faktiske)
5. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. november 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. november 2026
Sist bekreftet
1. november 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GA46280
- 2025-522904-26-00 (Ctis)
- 2025 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Ja
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