Actively Recruiting
A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Budoprutug (TNT119) in Subjects With Primary Membranous Nephropathy (PMN)
Led by Climb Bio, Inc. · Updated on 2026-04-30
45
Participants Needed
45
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating budoprutug, a humanized monoclonal antibody targeting CD19, in adults with primary membranous nephropathy (PMN) who have anti-PLA2R antibodies and persistent proteinuria despite optimized RAAS inhibitor treatment. This Phase 2, open-label study aims to assess the safety, pharmacodynamics, and preliminary efficacy of this investigational drug in this patient group. Participants will receive one of three sequential intravenous dose regimens of budoprutug. Each participant will receive single IV doses on Days 1, 15, 169, and 183. Approximately 45 subjects will be enrolled across three different dose cohorts. Following treatment, participants will be monitored through Week 48, with extended follow-up for B-cell recovery as needed. Throughout the study, researchers will track safety by recording treatment-emergent adverse events up to Week 48. They will also evaluate changes in total B cell count, anti-PLA2R antibodies, proteinuria, kidney function measures (eGFR, UACR), and remission rates. Participants will have regular assessments including laboratory tests and clinical evaluations to monitor these outcomes and ensure safety.
CONDITIONS
Brief Title
A Phase 2 Study of Budoprutug in Subjects With Primary Membranous Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of primary membranous nephropathy with positive anti-PLA2R antibodies
- CD19+ B cell count of 40 cells/μL or higher
- Urine protein-to-creatinine ratio (UPCR) of 2.0 g/g or higher
- Estimated glomerular filtration rate (eGFR) of 35 mL/min/1.73 m² or higher
- Stable treatment with RAAS inhibitors
- Blood pressure less than 150/90 mmHg at baseline
- Adequate blood, liver, and kidney function
- Willingness to use effective contraception (both sexes)
- Other inclusion criteria may apply
You will not qualify if you...
- Secondary membranous nephropathy
- Rapidly progressive glomerulonephritis or other types of glomerulopathies
- Prior B cell-depleting therapy within the past 24 weeks
- Recent use of immunosuppressant medications
- Active or high-risk infections
- History of cancer
- Pregnancy or breastfeeding
- Recent major surgery or hospitalization
- Other exclusion criteria may apply
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months
Participants receive intravenous doses of budoprutug on Day 1, Day 15, Day 169, and Day 183.
4 infusion visits
Duration - Up to 48 weeks
Participants are followed through Week 48 for safety, efficacy, and B-cell recovery assessments as needed.
Regular follow-up visits during observation period
Trial Site Locations
Total: 45 locations
1
Climb Bio Investigative Site #110
Denver, Colorado, United States, 80220
Actively Recruiting
2
Climb Bio Investigative Site #105
Orlando, Florida, United States, 32086
Actively Recruiting
3
Climb Bio Investigative Site #108
Atlanta, Georgia, United States, 30342
Actively Recruiting
4
Climb Bio Investigative Site #106
Indianapolis, Indiana, United States, 46268
Actively Recruiting
5
Climb Bio Investigative Site #101
Clifton Park, New York, United States, 12065
Actively Recruiting
6
Climb Bio Investigative Site #102
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
7
Climb Bio Investigative Site #103
El Paso, Texas, United States, 79932
Actively Recruiting
8
Climb Bio Investigative Site #104
Sherman, Texas, United States, 75092
Actively Recruiting
9
Climb Bio Investigative Site# 602
Buenos Aires, Argentina, B1629
Actively Recruiting
10
Climb Bio Investigative Site# 603
Buenos Aires, Argentina, B1888
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11
Climb Bio Investigative Site #601
CABA, Argentina, C1111
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12
Climb Bio Investigative Site #604
CABA, Argentina, C1425
Actively Recruiting
13
Climb Bio Investigative Site #605
Córdoba, Argentina, C1425
Not Yet Recruiting
14
Climb Bio Investigative Site #606
Santa Fe, Argentina, S3000
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15
Climb Bio Investigative Site #502
Belo Horizonte, Brazil, 30150-320
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16
Climb Bio Investigative Site #505
Minas Gerais, Brazil, 36010-570
Actively Recruiting
17
Climb Bio Investigative Site #506
Pernambuco, Brazil, 50670-901
Not Yet Recruiting
18
Climb Bio Investigative Site #501
Porto Alegre, Brazil, 90020-090
Actively Recruiting
19
Climb Bio Investigative Site #503
São Paulo, Brazil, 05403-000
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20
Climb Bio Investigative Site #504
São Paulo, Brazil, 05403-000
Actively Recruiting
21
Climb Bio Investigative Site #701
Temuco, Araucania, Chile, 4811230
Not Yet Recruiting
22
Climb Bio Investigative Site #703
Valdivia, Los Ríos Region, Chile, 5020000
Not Yet Recruiting
23
Climb Bio Investigative Site #702
Santiago, Santiago Metropolitan, Chile, 8320165
Not Yet Recruiting
24
Climb Bio Investigative Site #403
Beijing, Changping District, China, 102218
Not Yet Recruiting
25
Climb Bio Investigative Site #401
Beijing, Cheng District, China, 100034
Not Yet Recruiting
26
Climb Bio Investigative Site #408
Shenzhen, Guangdong, China, 518036
Not Yet Recruiting
27
Climb Bio Investigative Site #402
Wuxi, Jiangsu, China, 214023
Not Yet Recruiting
28
Climb Bio Investigative Site #407
Xi'an, Shaanxi, China, 710061
Not Yet Recruiting
29
Climb Bio Investigative Site #405
Jinan, Shandong, China, 250014
Not Yet Recruiting
30
Climb Bio Investigative Site #409
Yantai, Shandong, China, 264000
Not Yet Recruiting
31
Climb Bio Investigative Site #404
Yibin, Sichuan, China, 644000
Not Yet Recruiting
32
Climb Bio Investigative Site #406
Beijing, Xicheng District, China, 100044
Not Yet Recruiting
33
Climb Bio Investigative Site #903
Tbilisi, Georgia, 0112
Actively Recruiting
34
Climb Bio Investigative Site #902
Tbilisi, Georgia, 0114
Actively Recruiting
35
Climb Bio Investigative Site #901
Tbilisi, Georgia, 0144
Actively Recruiting
36
Climb Bio Investigative Site #204
Taichung, Taiwan, 404
Actively Recruiting
37
Climb Bio Investigative Site# 202
Taipei, Taiwan, 100
Not Yet Recruiting
38
Climb Bio Investigative Site# 201
Taipei, Taiwan, 110
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39
Climb Bio Investigative Site #205
Taipei, Taiwan, 112
Actively Recruiting
40
Climb Bio Investigative Site# 203
Taipei, Taiwan, 235
Not Yet Recruiting
41
Climb Bio Investigative Site #803
Ivano-Frankivsk, Ukraine, 76008
Actively Recruiting
42
Climb Bio Investigative Site# 801
Kyiv, Ukraine, 02125
Actively Recruiting
43
Climb Bio Investigative Site #805
Kyiv, Ukraine, 03151
Actively Recruiting
44
Climb Bio Investigative Site #804
Rivne, Ukraine, 33027
Actively Recruiting
45
Climb Bio Investigative Site #802
Ternopil, Ukraine, 46002
Actively Recruiting
Research Team
C
Climb Bio Study Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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