A Phase 2 Study of Budoprutug in Subjects With Primary Membranous Nephropathy

A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Budoprutug (TNT119) in Subjects With Primary Membranous Nephropathy (PMN)

To evaluate the safety and tolerability of three dose regimens of budoprutug in subjects with PMN

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 (ADCC). This Phase 2, open-label, multicenter study evaluates the safety, pharmacodynamics, and preliminary efficacy of three intravenous dose regimens of budoprutug in adult subjects with primary membranous nephropathy (PMN) who are anti-PLA2R antibody positive and have persistent proteinuria despite optimized RAAS inhibition. Approximately 45 subjects will be enrolled across three sequential dose cohorts, each receiving a single IV dose of budoprutug on Day 1, Day 15, Day 169 and Day 183. Subjects will be followed through Week 48, with extended follow-up for B-cell recovery as needed.

Inclusion Criteria:

• Confirmed diagnosis of PMN with positive anti-PLA2R antibodies
• CD19+ B cell count ≥40 cells/μL
• UPCR ≥2.0 g/g
• eGFR ≥35 mL/min/1.73 m²
• Stable RAAS inhibitor therapy
• Blood pressure <150/90 mmHg at baseline
• Adequate hematologic, hepatic, and renal function
• Willing to use effective contraception (both sexes)
• Other inclusion criteria may apply

Exclusion Criteria:

• Secondary Membranous Nephropathy
• Rapidly progressive glomerulonephritis or other glomerulopathies
• Prior B cell-depleting therapy within 24 weeks
• Recent use of immunosuppressants
• Active or high-risk infections
• History of malignancy
• Pregnancy or breastfeeding
• Recent major surgery or hospitalization
• Other exclusion criteria may apply