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

NCT07096843 | Recruiting Phase 2 FDA Drug

• 1 other identifier: TNT119-PMN-201
• Study Type: interventional
• Target: 45
• Locations: 8 countries
• Sites: 45

Brief Summary

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

Conditions

Primary Membranous Nephropathy

Keywords

PMN; Anti-CD19; PrisMN

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  Number of participants experiencing TEAEs, graded per NCI CTCAE v5.0.

  Up to Week 48

Secondary Outcomes (13)

• Change in total B Cell Count

  Up to Week 48

• Change in Anti-PLA2R Antibodies

  Up to Week 48

• Complete Remission Rate

  Week 48

• Complete or Partial Remission Rate

  Week 48

• Change in Proteinuria

  Up to Week 48

Study Arms (3)

Cohort 1: Dose Level A

EXPERIMENTAL

Drug: budoprutug

Cohort 2: Dose Level B

EXPERIMENTAL

Drug: budoprutug

Cohort 3: Dose Level C

EXPERIMENTAL

Drug: budoprutug

Interventions

budoprutug DRUG

Single IV dose of study product on Day 1, Day 15, Day 169 and Day 183

Also known as: TNT119

Cohort 1: Dose Level A; Cohort 2: Dose Level B; Cohort 3: Dose Level C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Climb Bio, Inc.: lead

Study Sites (45)

Climb Bio Investigative Site #110

Denver, Colorado, 80220, United States

RECRUITING

Climb Bio Investigative Site #105

Orlando, Florida, 32086, United States

RECRUITING

Climb Bio Investigative Site #108

Atlanta, Georgia, 30342, United States

RECRUITING

Climb Bio Investigative Site #106

Indianapolis, Indiana, 46268, United States

RECRUITING

Climb Bio Investigative Site #101

Clifton Park, New York, 12065, United States

RECRUITING

Climb Bio Investigative Site #102

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

Climb Bio Investigative Site #103

El Paso, Texas, 79932, United States

RECRUITING

Climb Bio Investigative Site #104

Sherman, Texas, 75092, United States

RECRUITING

Climb Bio Investigative Site# 602

Buenos Aires, B1629, Argentina

RECRUITING

Climb Bio Investigative Site# 603

Buenos Aires, B1888, Argentina

RECRUITING

Climb Bio Investigative Site #601

CABA, C1111, Argentina

RECRUITING

Climb Bio Investigative Site #604

CABA, C1425, Argentina

RECRUITING

Climb Bio Investigative Site #605

Córdoba, C1425, Argentina

NOT YET RECRUITING

Climb Bio Investigative Site #606

Santa Fe, S3000, Argentina

RECRUITING

Climb Bio Investigative Site #502

Belo Horizonte, 30150-320, Brazil

RECRUITING

Climb Bio Investigative Site #505

Minas Gerais, 36010-570, Brazil

RECRUITING

Climb Bio Investigative Site #506

Pernambuco, 50670-901, Brazil

NOT YET RECRUITING

Climb Bio Investigative Site #501

Porto Alegre, 90020-090, Brazil

RECRUITING

Climb Bio Investigative Site #503

São Paulo, 05403-000, Brazil

RECRUITING

Climb Bio Investigative Site #504

São Paulo, 05403-000, Brazil

RECRUITING

Climb Bio Investigative Site #701

Temuco, Araucania, 4811230, Chile

NOT YET RECRUITING

Climb Bio Investigative Site #703

Valdivia, Los Ríos Region, 5020000, Chile

NOT YET RECRUITING

Climb Bio Investigative Site #702

Santiago, Santiago Metropolitan, 8320165, Chile

NOT YET RECRUITING

Climb Bio Investigative Site #403

Beijing, Changping District, 102218, China

NOT YET RECRUITING

Climb Bio Investigative Site #401

Beijing, Cheng District, 100034, China

NOT YET RECRUITING

Climb Bio Investigative Site #408

Shenzhen, Guangdong, 518036, China

NOT YET RECRUITING

Climb Bio Investigative Site #402

Wuxi, Jiangsu, 214023, China

NOT YET RECRUITING

Climb Bio Investigative Site #407

Xi'an, Shaanxi, 710061, China

NOT YET RECRUITING

Climb Bio Investigative Site #405

Jinan, Shandong, 250014, China

NOT YET RECRUITING

Climb Bio Investigative Site #409

Yantai, Shandong, 264000, China

NOT YET RECRUITING

Climb Bio Investigative Site #404

Yibin, Sichuan, 644000, China

NOT YET RECRUITING

Climb Bio Investigative Site #406

Beijing, Xicheng District, 100044, China

NOT YET RECRUITING

Climb Bio Investigative Site #903

Tbilisi, 0112, Georgia

RECRUITING

Climb Bio Investigative Site #902

Tbilisi, 0114, Georgia

RECRUITING

Climb Bio Investigative Site #901

Tbilisi, 0144, Georgia

RECRUITING

Climb Bio Investigative Site #204

Taichung, 404, Taiwan

RECRUITING

Climb Bio Investigative Site# 202

Taipei, 100, Taiwan

NOT YET RECRUITING

Climb Bio Investigative Site# 201

Taipei, 110, Taiwan

RECRUITING

Climb Bio Investigative Site #205

Taipei, 112, Taiwan

RECRUITING

Climb Bio Investigative Site# 203

Taipei, 235, Taiwan

NOT YET RECRUITING

Climb Bio Investigative Site #803

Ivano-Frankivsk, 76008, Ukraine

RECRUITING

Climb Bio Investigative Site# 801

Kyiv, 02125, Ukraine

RECRUITING

Climb Bio Investigative Site #805

Kyiv, 03151, Ukraine

RECRUITING

Climb Bio Investigative Site #804

Rivne, 33027, Ukraine

RECRUITING

Climb Bio Investigative Site #802

Ternopil, 46002, Ukraine

RECRUITING

Central Study Contacts

Climb Bio Study Director

CONTACT

+1 866 857 2596; clinicaltrials@climbbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CL (3); CN (9); UA (5); GE (3); TW (5); US (8); AR (6); BR (6)