RecruitingPhase 1Phase 2NCT07043946

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)

Sponsor

Climb Bio, Inc.

Enrollment

24 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

ITP Immune Thrombocytopenia (ITP)Monoclonal Biologics Anti-CD19

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Budoprutug for people with anti-cd19, biologics, and other related conditions. The study is currently recruiting participants at 20 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBudoprutug

Single IV dose of study product on Day 1 and Day 15

Locations(20)

Climb Bio Investigative Site #359202

Plovdiv, Bulgaria

Climb Bio Investigative Site #359203

Plovdiv, Bulgaria

Climb Bio Investigative Site #359201

Sofia, Bulgaria

Climb Bio Investigative Site #300204

Athens, Attica, Greece

Climb Bio Investigative Site #300203

Chaïdári, Attica, Greece

Climb Bio Investigative Site #300202

Ioannina, Greece

Climb Bio Investigative Site #300201

Thessaloniki, Greece

Climb Bio Investigative Site #381201

Belgrade, Serbia

Climb Bio Investigative Site #381202

Belgrade, Serbia

Climb Bio Investigative Site #381203

Novi Sad, Serbia

Climb Bio Investigative Site #340206

Burgos, Spain

Climb Bio Investigative Site #340204

Madrid, Spain

Climb Bio Investigative Site #340202

San Pedro, Spain

Climb Bio Investigative Site #340203

Valencia, Spain

Climb Bio Investigative Site #380208

Cherkasy, Ukraine

Climb Investigative Site #380204

Ivano-Frankivsk, Ukraine

Climb Investigative Site #2380203

Kyiv, Ukraine

Climb Investigative Site #380202

Kyiv, Ukraine

Climb Investigative Site #380206

Kyiv, Ukraine

Climb Investigative Site #380201

Lviv, Ukraine

View Full Details on ClinicalTrials.gov

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NCT07043946

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