Budoprutug for adults with immune thrombocytopenia (ITP)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, sequential-cohort Phase 1b/2a dose-escalation and expansion study gives budoprutug as two IV infusions 14 days apart to adults with ITP and platelet counts below 30,000/µL. The primary focus is on safety and tolerability, with secondary evaluations of pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy such as platelet response. Dosing will proceed in ascending cohorts to identify tolerable dose levels and characterize biological effects on CD19+ B cells. Eligible patients must have confirmed low platelet counts despite prior therapy and meet baseline coagulation and laboratory criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18 years at the time of consent.
2. 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.
3. 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.

Exclusion Criteria:

1. 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.
2. Diagnosis of paroxysmal nocturnal hemoglobinuria, Evan's Syndrome, or other bleeding disorders affecting safety or data integrity.
3. Prior B-cell depleting therapy (e.g., rituximab) within 24 weeks before first dose or planned during the study.
4. 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.
5. Immunosuppressants (excluding corticosteroids) within 30 days or 5× half-life before Screening; alkylating agents within 180 days.
6. IVIg treatment within 90 days prior to Screening.
7. Active ITP treatment (other than steroids or TPO agonists) within 30 days or 5× half-life before first dose, unless approved by Medical Monitor.
8. Active, chronic, or latent infections including hepatitis B/C or HIV.
9. Active TB or high TB risk.

Where it's running

• Climb Bio Investigative Site #359202
  Plovdiv, Bulgaria Recruiting
• Climb Bio Investigative Site #359203
  Plovdiv, Bulgaria Recruiting
• Climb Bio Investigative Site #359201
  Sofia, Bulgaria Recruiting
• Climb Bio Investigative Site #300204
  Athens, Attica, Greece Recruiting
• Climb Bio Investigative Site #300203
  Chaïdári, Attica, Greece Recruiting
• Climb Bio Investigative Site #300202
  Ioannina, Greece Recruiting

Study contacts

• Study coordinator: Climb Bio Study Director
• Email: clinicaltrials@climbbio.com
• Phone: +1 866 857 2596

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.