A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Budoprutug (TNT119) in Subjects With Primary Membranous Nephropathy (PMN)
Climb Bio, Inc.
Summary
To evaluate the safety and tolerability of three dose regimens of budoprutug in subjects with PMN
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 (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 cohor…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Drugbudoprutug
Single IV dose of study product on Day 1, Day 15, Day 169 and Day 183
Locations (45)
- Climb Bio Investigative Site #110Denver, Colorado
- Climb Bio Investigative Site #105Orlando, Florida
- Climb Bio Investigative Site #108Atlanta, Georgia
- Climb Bio Investigative Site #106Indianapolis, Indiana
- Climb Bio Investigative Site #101Clifton Park, New York
- Climb Bio Investigative Site #102Philadelphia, Pennsylvania