Lupus Erythematosus, SystemicPhase 1NCT07629583
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
A Phase 1 study testing Cevostamab and Tocilizumab in people with Lupus Erythematosus, Systemic, run by Genentech, Inc. at 11 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Cevostamab and Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 11 sitesin 6 countries
- Study dates
- 2 Nov 2026to 29 Mar 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
11 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: GA46280 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
11 sites in 6 countries
Brazil4 sites, 4 recruiting
- Recruiting
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90560-032
- Recruiting
Hospital de Clnicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90630-165
- Recruiting
Hospital das Clínicas FMRP-USP
Ribeirão Preto, São Paulo, 14015-010
- Recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
Sao Jose Rio Preto, São Paulo, 15090-000
China3 sites, 3 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
- Recruiting
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055
Australia1 site, 1 recruiting
- Recruiting
Royal Melbourne Hospital
Parkville, Victoria, 3052
France1 site, 1 recruiting
- Recruiting
Hopital Rangueil
Toulouse, Haute Garonne, 31059
Italy1 site, 1 recruiting
- Recruiting
Istituto Clinico Humanitas
Rozzano, Lombardy, 20089
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
About this study
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
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
- Being tested
- Cevostamab, Tocilizumab
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CevostamabDrug
Also called RO7187797
Participants will receive cevostamab IV as per the schedule given in the protocol.
TocilizumabDrug
Also called Actemra/RoActemra
Tocilizumab may be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Cevostamab; Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events (AEs)
Measured: Up to approximately 52 weeks
Secondary outcomes (7)
Serum Concentration of Cevostamab
Measured: Up to approximately 52 weeks
Area Under the Concentration-Time Curve (AUC) of Cevostamab
Measured: Up to approximately 52 weeks
Maximum Observed Serum Concentration (Cmax) of Cevostamab
Measured: Up to approximately 52 weeks
Minimum Observed Serum Concentration (Cmin) of Cevostamab
Measured: Up to approximately 52 weeks
Clearance (CL) of Cevostamab
Measured: Up to approximately 52 weeks
Volume of Distribution at Steady State (Vdss) of Cevostamab
Measured: Up to approximately 52 weeks
Change from Baseline in the Presence Anti-Drug Antibodies (ADAs)
Measured: Up to approximately 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start2 Nov 2026
- Primary completion29 Mar 2030 (estimated)
- Study completion29 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629583
- Sponsor's protocol ID
- GA46280
- Other IDs
- 2025-522904-26-00, 2025
- Status last verified
- Nov 2026
- First submitted
- 1 Jun 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07629583
- Acronym / sponsor ID
- GA46280
- Conditions
- Lupus Erythematosus, Systemic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2026 (actual)
- Primary completion
- 29 Mar 2030 (estimated)
- Study completion
- 29 Mar 2030 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation and Expansion | Experimental | Drug: Cevostamab, Drug: TocilizumabThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CevostamabAlso: RO7187797Participants will receive cevostamab IV as per the schedule given in the protocol. | Drug | Dose Escalation and Expansion |
| TocilizumabAlso: Actemra/RoActemraTocilizumab may be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event. | Drug | Dose Escalation and Expansion |
Primary outcome
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to approximately 52 weeks
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Lupus Erythematosus, Systemic
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reference Study ID Number: GA46280 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cevostamab and Tocilizumab in people with Lupus Erythematosus, Systemic, run by Genentech, Inc. at 11 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Brazil, China, Australia, France, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: GA46280 https://forpatients.roche.com/ No attachments to email below. (888-662-6728, global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Adverse Events (AEs) (time frame: Up to approximately 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.