NCT07043946

A Phase 1b/2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP)

A Phase 1b/2a, Open-Label, Sequential-Cohort, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Effectiveness of Budoprutug (TNT119) in Subjects With Immune Thrombocytopenia (ITP)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Climb Bio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective is to assess the safety and tolerability of budoprutug in adults with ITP. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.

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. This Phase 1b/2a, open-label, sequential-cohort, dose escalation and expansion study will evaluate the safety, tolerability, PK, PD, and preliminary clinical effectiveness of budoprutug in subjects with ITP. Budoprutug will be administered as two (2) IV infusions 14 days apart in ascending dose cohorts of patients aged 18 years and above with a platelet count \< 30,000/µL despite an adequate trial of at least one prior therapeutic attempt.

Conditions

• Immune Thrombocytopenia (ITP)
• ITP
• Biologics
• Monoclonal
• Anti-CD19

Interventions

Type	Name	Description
DRUG	Budoprutug	Single IV dose of study product on Day 1 and Day 15

Timeline

• Start date: 2025-06-30
• Primary completion: 2027-08-01
• Completion: 2028-08-01
• First posted: 2025-06-29
• Last updated: 2026-03-27

Locations

20 sites across 5 countries: Bulgaria, Greece, Serbia, Spain, Ukraine

Regulatory

• FDA-regulated drug study