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

April 28, 2026 updated by: Climb Bio, Inc.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B1629
        • Recruiting
        • Climb Bio Investigative Site# 602
      • Buenos Aires, Argentina, B1888
        • Recruiting
        • Climb Bio Investigative Site# 603
      • CABA, Argentina, C1111
        • Recruiting
        • Climb Bio Investigative Site #601
      • CABA, Argentina, C1425
        • Recruiting
        • Climb Bio Investigative Site #604
      • Córdoba, Argentina, C1425
        • Not yet recruiting
        • Climb Bio Investigative Site #605
      • Santa Fe, Argentina, S3000
        • Recruiting
        • Climb Bio Investigative Site #606
  • Brazil
      • Belo Horizonte, Brazil, 30150-320
        • Recruiting
        • Climb Bio Investigative Site #502
      • Minas Gerais, Brazil, 36010-570
        • Recruiting
        • Climb Bio Investigative Site #505
      • Pernambuco, Brazil, 50670-901
        • Not yet recruiting
        • Climb Bio Investigative Site #506
      • Porto Alegre, Brazil, 90020-090
        • Recruiting
        • Climb Bio Investigative Site #501
      • São Paulo, Brazil, 05403-000
        • Recruiting
        • Climb Bio Investigative Site #503
      • São Paulo, Brazil, 05403-000
        • Recruiting
        • Climb Bio Investigative Site #504
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4811230
        • Not yet recruiting
        • Climb Bio Investigative Site #701
    • Los Ríos Region
      • Valdivia, Los Ríos Region, Chile, 5020000
        • Not yet recruiting
        • Climb Bio Investigative Site #703
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 8320165
        • Not yet recruiting
        • Climb Bio Investigative Site #702
  • China
    • Changping District
      • Beijing, Changping District, China, 102218
        • Not yet recruiting
        • Climb Bio Investigative Site #403
    • Cheng District
      • Beijing, Cheng District, China, 100034
        • Not yet recruiting
        • Climb Bio Investigative Site #401
    • Guangdong
      • Shenzhen, Guangdong, China, 518036
        • Not yet recruiting
        • Climb Bio Investigative Site #408
    • Jiangsu
      • Wuxi, Jiangsu, China, 214023
        • Not yet recruiting
        • Climb Bio Investigative Site #402
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Not yet recruiting
        • Climb Bio Investigative Site #407
    • Shandong
      • Jinan, Shandong, China, 250014
        • Not yet recruiting
        • Climb Bio Investigative Site #405
      • Yantai, Shandong, China, 264000
        • Not yet recruiting
        • Climb Bio Investigative Site #409
    • Sichuan
      • Yibin, Sichuan, China, 644000
        • Not yet recruiting
        • Climb Bio Investigative Site #404
    • Xicheng District
      • Beijing, Xicheng District, China, 100044
        • Not yet recruiting
        • Climb Bio Investigative Site #406
  • Georgia
      • Tbilisi, Georgia, 0112
        • Recruiting
        • Climb Bio Investigative Site #903
      • Tbilisi, Georgia, 0114
        • Recruiting
        • Climb Bio Investigative Site #902
      • Tbilisi, Georgia, 0144
        • Recruiting
        • Climb Bio Investigative Site #901
  • Taiwan
      • Taichung, Taiwan, 404
        • Recruiting
        • Climb Bio Investigative Site #204
      • Taipei, Taiwan, 100
        • Not yet recruiting
        • Climb Bio Investigative Site# 202
      • Taipei, Taiwan, 235
        • Not yet recruiting
        • Climb Bio Investigative Site# 203
      • Taipei, Taiwan, 110
        • Recruiting
        • Climb Bio Investigative Site# 201
      • Taipei, Taiwan, 112
        • Recruiting
        • Climb Bio Investigative Site #205
  • Ukraine
      • Ivano-Frankivsk, Ukraine, 76008
        • Recruiting
        • Climb Bio Investigative Site #803
      • Kyiv, Ukraine, 02125
        • Recruiting
        • Climb Bio Investigative Site# 801
      • Kyiv, Ukraine, 03151
        • Recruiting
        • Climb Bio Investigative Site #805
      • Rivne, Ukraine, 33027
        • Recruiting
        • Climb Bio Investigative Site #804
      • Ternopil, Ukraine, 46002
        • Recruiting
        • Climb Bio Investigative Site #802
  • United States
    • Colorado
      • Denver, Colorado, United States, 80220
        • Recruiting
        • Climb Bio Investigative Site #110
    • Florida
      • Orlando, Florida, United States, 32086
        • Recruiting
        • Climb Bio Investigative Site #105
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Climb Bio Investigative Site #108
    • Indiana
      • Indianapolis, Indiana, United States, 46268
        • Recruiting
        • Climb Bio Investigative Site #106
    • New York
      • Clifton Park, New York, United States, 12065
        • Recruiting
        • Climb Bio Investigative Site #101
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Not yet recruiting
        • Climb Bio Investigative Site #102
    • Texas
      • El Paso, Texas, United States, 79932
        • Recruiting
        • Climb Bio Investigative Site #103
      • Sherman, Texas, United States, 75092
        • Recruiting
        • Climb Bio Investigative Site #104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to Week 48
Number of participants experiencing TEAEs, graded per NCI CTCAE v5.0.
Up to Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in total B Cell Count
Time Frame: Up to Week 48
Absolute and % change in total number of peripheral B cells over time.
Up to Week 48
Change in Anti-PLA2R Antibodies
Time Frame: Up to Week 48
Change from Baseline in anti-PLA2R antibody titers over time.
Up to Week 48
Complete Remission Rate
Time Frame: Week 48
Proportion of subjects who achieve complete remission at Week 48.
Week 48
Complete or Partial Remission Rate
Time Frame: Week 48
Proportion of subjects who achieve complete or partial remission at Week 48.
Week 48
Change in Proteinuria
Time Frame: Up to Week 48
Change from Baseline in proteinuria (measured via urine protein-creatinine ratio, UPCR) over time.
Up to Week 48
Change in UACR
Time Frame: Up to Week 48
Change in urine albumin-to-creatinine ratio over time.
Up to Week 48
Change in eGFR
Time Frame: Up to Week 48
Change from Baseline in eGFR over time.
Up to Week 48
Area Under the Curve (AUC)
Time Frame: Up to Week 48
Measurement of the area under the drug concentration-time curve.
Up to Week 48
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Up to Week 48
Measurement of the maximum observed plasma concentration.
Up to Week 48
Time to Maximum Observed Concentration (Tmax)
Time Frame: Up to Week 48
Measurement of the time to maximum observed concentration.
Up to Week 48
Terminal Half-Life (T1/2)
Time Frame: Up to Week 48
Measurement of the terminal half-life in days.
Up to Week 48
Apparent Clearance (CL/F)
Time Frame: Up to Week 48
Measurement of the apparent clearance in L/hour.
Up to Week 48
Volume of Distribution (Vd)
Time Frame: Up to Week 48
Measurement of the volume of distribution in liters.
Up to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Climb Bio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

July 24, 2025

First Submitted That Met QC Criteria

July 24, 2025

First Posted (Actual)

July 31, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNT119-PMN-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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