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Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 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 ≥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

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, Colorado 80220

Climb Bio Investigative Site #105
Orlando, Florida 32086

Climb Bio Investigative Site #108
Atlanta, Georgia 30342

Climb Bio Investigative Site #106
Indianapolis, Indiana 46268

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

Climb Bio Investigative Site #103
El Paso, Texas 79932

Climb Bio Investigative Site #104
Sherman, Texas 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.