Budoprutug for adults with systemic lupus erythematosus that has not responded to standard treatment
Tests budoprutug at rising doses in adults with active systemic lupus erythematosus.
Plain-language title generated from the registry record
Registry title: A Phase 1b/2a Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
Key facts
- Where
- Baoji, Beijing, Bengbu, Changsha, Hefei, Mianyang, Nanchang, Suzhou, Taiyuan, and Zaozhuang, ChinaSee the 10 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active lupus (SLE) with positive lupus antibodies, whose disease did not respond well enough to earlier treatment. They get budoprutug as 2 infusions 14 days apart.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Active lupus (SLE) with positive lupus antibodies and a SLEDAI 2K score of 6 or more at screening.
- Earlier treatment
- Inadequate response to at least one earlier treatment for lupus.
- Biomarker or test result
- Seropositive disease (positive lupus antibodies).
Main reasons for not taking part
- Active lupus affecting the brain or mind (neuropsychiatric SLE)
- Active lupus nephritis type III or IV that needs, or recently needed, induction treatment (within 12 weeks)
- Another autoimmune or inflammatory disease that could confuse the results or add risk
- Active infection throughout the body, or a history of serious, chronic, recurrent, latent or recent infections
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07564596, who can take part
Where in China
- Baoji Central HospitalBaoji, ChinaTaking people
- Peking University People's HospitalBeijing, ChinaTaking people
- The First Affiliated Hospital of Bengbu Medical CollegeBengbu, ChinaNot yet recruiting
- Xiangya Second Hospital of Central South UniversityChangsha, ChinaNot yet recruiting
- The First Affiliated Hospital of the University of ScienceHefei, ChinaNot yet recruiting
- Mianyang Central HospitalMianyang, ChinaNo longer taking part
- The First Affiliated Hospital of NanchangNanchang, ChinaNot yet recruiting
- The Second Affiliated Hospital of Soochow UniversitySuzhou, ChinaNot yet recruiting
- Shanxi Bethune HospitalTaiyuan, ChinaTaking people
- Zaozhuang Municipal HospitalZaozhuang, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Climb Bio, Inc.
- Trial code
- NCT07564596
- Record updated
- 20 October 2026
- Original description
Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity. This Phase 1b/2a, open-label study will evaluate budoprutug in ascending dose cohorts of patients aged 18 years and above with active, seropositive SLE and inadequate response to standard therapy. The study will also assess the pharmacokinetics, pharmacodynamics and early indications of efficacy of budoprutug in SLE, where pharmacodynamics will be evaluated as the change in the number of B cells and immunoglobulins (antibodies) in the blood over time. Budoprutug will be administered as two (2) IV infusions 14 days apart in ascending dose cohorts.Read full original descriptionShow less
A Phase 1b/2a Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Budoprutug (TNT119) in Adult Subjects With Systemic Lupus Erythematosus (SLE)
Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity. This Phase 1b/2a, open-label study will evaluate budoprutug in ascending dose cohorts of patients aged 18 years and above with active, seropositive SLE and inadequate response to standard therapy. The study will also assess the pharmacokinetics, pharmacodynamics and early indications of efficacy of budoprutug in SLE, where pharmacodynamics will be evaluated as the change in the number of B cells and immunoglobulins (antibodies) in the blood over time. Budoprutug will be administered as two (2) IV infusions 14 days apart in ascending dose cohorts.
Inclusion: Aged 18 to 65 years at the time of consent; Diagnosis of SLE according to the 2019 European League Against. Rheumatism and the American College of Rheumatology (ACR) classification criteria; Active, seropositive disease, with SLEDAI 2K >=6 at screening; Inadequate response to at least one therapeutic intervention.
Exclusion: Active lupus nephritis type III or IV that is expected to require induction therapy during the study or recently treated with induction therapy within 12 weeks; Prior diagnosis of, or fulfills diagnostic criteria for, other autoimmune or inflammatory disease that may confound clinical assessments or increase subject risk in the study; Active systemic infection or history of chronic, recurrent, latent, or recent serious infections; Active neuropsychiatric SLE.