NCT07564596RecruitingPhase 1/2
A Phase 1b/2a Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
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)
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 27 Apr 2026
- Start date
- 30 Jun 2026
- Primary completion date
- Sept 2027
- Lead sponsor
- Climb Bio, Inc.
- Diseases
- Lupus (SLE)
- NCT number
- NCT07564596
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 30
- From 30 Jun 2026 to the primary completion date, Sept 2027
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.
Other
- Active neuropsychiatric SLE.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baoji Central Hospital Coordinator of this site? Confirm its status | Baoji | China | Recruiting |
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The First Affiliated Hospital of Bengbu Medical College Coordinator of this site? Confirm its status | Bengbu | China | Not yet recruiting |
| Xiangya Second Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| The First Affiliated Hospital of the University of Science Coordinator of this site? Confirm its status | Hefei | China | Not yet recruiting |
| Mianyang Central Hospital Coordinator of this site? Confirm its status | Mianyang | China | Active, not recruiting |
| The First Affiliated Hospital of Nanchang Coordinator of this site? Confirm its status | Nanchang | China | Not yet recruiting |
| The Second Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Not yet recruiting |
| Shanxi Bethune Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
| Zaozhuang Municipal Hospital Coordinator of this site? Confirm its status | Zaozhuang | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.