To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
NCT07629583 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2026-08-07
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).
Conditions
- Lupus Erythematosus, Systemic
Interventions
- DRUG
-
Cevostamab
Participants will receive cevostamab IV as per the schedule given in the protocol.
- DRUG
-
Tocilizumab may be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.
Sponsors & Collaborators
-
Genentech, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-10-31
- Primary Completion
- 2030-03-29
- Completion
- 2030-03-29
- FDA Drug
- Yes
Countries
- Spain
Study Locations
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