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

Purpose

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

Condition

  • Primary Membranous Nephropathy

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts 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 ≥40 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1: Dose Level A
  • Drug: budoprutug
    Single IV dose of study product on Day 1, Day 15, Day 169 and Day 183
    Other names:
    • TNT119
Experimental
Cohort 2: Dose Level B
  • Drug: budoprutug
    Single IV dose of study product on Day 1, Day 15, Day 169 and Day 183
    Other names:
    • TNT119
Experimental
Cohort 3: Dose Level C
  • Drug: budoprutug
    Single IV dose of study product on Day 1, Day 15, Day 169 and Day 183
    Other names:
    • TNT119

Recruiting Locations

Climb Bio Investigative Site #110
Denver 5419384, Colorado 5417618 80220

Climb Bio Investigative Site #105
Orlando 4167147, Florida 4155751 32086

Climb Bio Investigative Site #108
Atlanta 4180439, Georgia 4197000 30342

Climb Bio Investigative Site #106
Indianapolis 4259418, Indiana 4921868 46268

Climb Bio Investigative Site #101
Clifton Park 5112961, New York 5128638 12065

Climb Bio Investigative Site #103
El Paso 5520993, Texas 4736286 79932

Climb Bio Investigative Site #104
Sherman 4728328, Texas 4736286 75092

More Details

Status
Recruiting
Sponsor
Climb Bio, Inc.

Study Contact

Climb Bio Study Director
+1 866 857 2596
clinicaltrials@climbbio.com

Detailed 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 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.