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

July 14, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
      • 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
        • 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
        • Recruiting
        • Climb Bio Investigative Site #401
    • Guangdong
      • Shenzhen, Guangdong, China, 518036
        • Not yet recruiting
        • Climb Bio Investigative Site #408
    • Jiangsu
      • Wuxi, Jiangsu, China, 214023
        • 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, 110
        • Recruiting
        • Climb Bio Investigative Site# 201
      • Taipei, Taiwan, 112
        • Recruiting
        • Climb Bio Investigative Site #205
      • Taipei, Taiwan, 100
        • Recruiting
        • Climb Bio Investigative Site# 202
      • Taipei, Taiwan, 235
        • Recruiting
        • Climb Bio Investigative Site# 203
  • 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
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Not yet recruiting
        • Climb Bio Investigative Site #111
    • New York
      • Clifton Park, New York, United States, 12065
        • Recruiting
        • Climb Bio Investigative Site #101
    • Texas
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 25, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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