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Taking people in SerbiaPhase 1/2

Budoprutug for adults with immune thrombocytopenia, tested for safety

Tests budoprutug for safety in adults with immune thrombocytopenia.

Key facts

Who runs it
Climb Bio, Inc.
Where
Belgrade and Novi Sad, SerbiaSee the 3 sitesAlso in 4 other countries, 17 sites
Trial code
Registry title
A Phase 1b/2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP)
Status
Recruiting
Phase
Phase 1/2
People taking part
24 people, planned
Started
30 Jun 2025
Expected to end
Aug 2028
Type of study
Interventional, 4 groups
Treatments tested
  • Budoprutug
Record updated
27 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with immune thrombocytopenia (ITP), a condition with a low count of platelets (blood cells that help clotting). It tests the safety of budoprutug.

Age
18 years and older.
Sex
All sexes can join.
Disease stage
Platelet count below 30,000/µL, confirmed on 2 occasions at least 5 days apart, but no more than 14 days apart.
Earlier treatment
People must have tried at least one earlier ITP treatment that did not raise platelets enough. Cannot join after B-cell depleting therapy (e.g., rituximab) within 24 weeks, IVIg within 90 days, other immunosuppressants (not corticosteroids) within 30 days, or alkylating agents within 180 days.
Biomarker or test result
Blood clotting tests (partial thromboplastin time, prothrombin time) and total bilirubin below 1.5 x the upper limit of normal, or INR below 1.5. CD19+ B cell count of at least 80 cells/µL (or 40 cells/µL after earlier B-cell depleting therapy).

Main reasons for not taking part

  • Paroxysmal nocturnal hemoglobinuria, Evan's Syndrome, or other bleeding disorders.
  • Regular use of blood thinners or antiplatelet drugs such as aspirin; occasional NSAID use is allowed.
  • Other active ITP treatment (not steroids or TPO agonists) within 30 days, unless the medical monitor approves.
  • Active, chronic or hidden infections, including hepatitis B/C or HIV.
  • Active tuberculosis (TB) or high TB risk.

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • Aged 18 years at the time of consent
  • Platelet count < 30,000/µL despite an adequate trial of at least one prior therapeutic attempt. Platelet counts of < 30,000/µL must be confirmed on 2 occasions at least 5 days apart, but no more than 14 days apart
  • Partial thromboplastin time < 1.5 x upper limit of normal (ULN), prothrombin time < 1.5 x ULN, total bilirubin < 1.5 x ULN unless due to Gilbert's syndrome, or an international normalized ratio < 1.5 at screening

Who cannot take part

  • Prior B-cell depleting therapy (e.g., rituximab) within 24 weeks before first dose or planned during the study
  • Chronic use of anticoagulants or antiplatelet agents (e.g., aspirin, NSAIDs, thienopyridines) within 14 days before dosing through follow-up. Intermittent NSAID use is allowed
  • Immunosuppressants (excluding corticosteroids) within 30 days or 5× half-life before Screening; alkylating agents within 180 days
  • IVIg treatment within 90 days prior to Screening
  • Active ITP treatment (other than steroids or TPO agonists) within 30 days or 5× half-life before first dose, unless approved by Medical Monitor
  • Diagnosis of paroxysmal nocturnal hemoglobinuria, Evan's Syndrome, or other bleeding disorders affecting safety or data integrity
  • Active, chronic, or latent infections including hepatitis B/C or HIV
  • CD19+ B cell count < 80 cells/µL at Screening, or < 40 cells/µL if B-cell depleting therapy was received within 24 weeks to 2 years prior
  • Active TB or high TB risk

Where in Serbia

Also in 4 other countries, 17 sites

  • BelgradeHospital not named in the registryContact: Climb Bio Study DirectorTaking people
  • BelgradeHospital not named in the registryContact: Climb Bio Study DirectorTaking people
  • Novi SadHospital not named in the registryContact: Climb Bio Study DirectorTaking people

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • Cohort 1: Dose Level ATreatment being tested

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

    Treatment: Budoprutug

  • Cohort 2: Dose Level BTreatment being tested

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

    Treatment: Budoprutug

  • Cohort 3: Dose Level CTreatment being tested

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

    Treatment: Budoprutug

  • Dose Expansion CohortTreatment being tested

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

    Treatment: Budoprutug

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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)
Plain-language title
Budoprutug for adults with immune thrombocytopenia, tested for safetyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
27 March 2026