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A Phase 1b/2a Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
Sponsor: Climb Bio, Inc.
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-06-30
Completion Date
2027-09
Last Updated
2026-10-20
Healthy Volunteers
No
Conditions
Interventions
Budoprutug
Single IV dose of study product on Day 1 and Day 15
Locations (10)
Mianyang Central Hospital
Mianyang, Sichuan, China
Baoji Central Hospital
Baoji, China
Peking University People's Hospital
Beijing, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
Xiangya Second Hospital of Central South University
Changsha, China
The First Affiliated Hospital of the University of Science
Hefei, China
The First Affiliated Hospital of Nanchang
Nanchang, China
The Second Affiliated Hospital of Soochow University
Suzhou, China
Shanxi Bethune Hospital
Taiyuan, China
Zaozhuang Municipal Hospital
Zaozhuang, China