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

Last updated: January 5, 2026
Sponsor: Climb Bio, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Platelet Disorders

Immune Thrombocytopenia (Itp)

White Cell Disorders

Treatment

Budoprutug

Clinical Study ID

NCT07043946
TNT119-ITP-201
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 priortherapeutic attempt. Platelet counts of < 30,000/µL must be confirmed on 2 occasionsat 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 aninternational normalized ratio < 1.5 at screening.

Exclusion

Exclusion Criteria:

  1. CD19+ B cell count < 80 cells/µL at Screening, or < 40 cells/µL if B-cell depletingtherapy was received within 24 weeks to 2 years prior.

  2. Diagnosis of paroxysmal nocturnal hemoglobinuria, Evan's Syndrome, or other bleedingdisorders affecting safety or data integrity.

  3. Prior B-cell depleting therapy (e.g., rituximab) within 24 weeks before first doseor 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 NSAIDuse is allowed.

  5. Immunosuppressants (excluding corticosteroids) within 30 days or 5× half-life beforeScreening; 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.

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Budoprutug
Phase: 1/2
Study Start date:
June 30, 2025
Estimated Completion Date:
August 31, 2028

Study 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.

Connect with a study center

  • Climb Bio Investigative Site #359202

    Plovdiv 728193, 4002
    Bulgaria

    Active - Recruiting

  • Climb Bio Investigative Site #359203

    Plovdiv 728193, 4003
    Bulgaria

    Active - Recruiting

  • Climb Bio Investigative Site #359201

    Sofia 727011, 1797
    Bulgaria

    Active - Recruiting

  • Climb Bio Investigative Site #300204

    Athens 264371, Attica 6692632 11527
    Greece

    Site Not Available

  • Climb Bio Investigative Site #300203

    Chaïdári 260183, Attica 6692632 12462
    Greece

    Site Not Available

  • Climb Bio Investigative Site #300202

    Ioannina 261779, 45500
    Greece

    Site Not Available

  • Climb Bio Investigative Site #300201

    Thessaloniki 734077, 57010
    Greece

    Site Not Available

  • Climb Bio Investigative Site #381201

    Belgrade,
    Serbia

    Site Not Available

  • Climb Bio Investigative Site #381202

    Belgrade,
    Serbia

    Site Not Available

  • Climb Bio Investigative Site #381201

    Belgrade 792680,
    Serbia

    Active - Recruiting

  • Climb Bio Investigative Site #381202

    Belgrade 792680,
    Serbia

    Active - Recruiting

  • Climb Bio Investigative Site #381203

    Novi Sad,
    Serbia

    Site Not Available

  • Climb Bio Investigative Site #381203

    Novi Sad 3194360,
    Serbia

    Active - Recruiting

  • Climb Bio Investigative Site #340202

    Cáceres 2520611, Attiki 100003
    Spain

    Site Not Available

  • Climb Bio Investigative Site #340206

    Burgos 3127461, 9006
    Spain

    Site Not Available

  • Climb Bio Investigative Site #340204

    Madrid 3117735, 28041
    Spain

    Site Not Available

  • Climb Bio Investigative Site #340202

    San Pedro 2511250,
    Spain

    Site Not Available

  • Climb Bio Investigative Site #340203

    Valencia 2509954, 46010
    Spain

    Site Not Available

  • Climb Investigative Site

    Ivano-Frankivs'k,
    Ukraine

    Active - Recruiting

  • Climb Investigative Site #380204

    Ivano-Frankivs'k,
    Ukraine

    Site Not Available

  • Climb Investigative Site #380204

    Ivano-Frankivsk 707471,
    Ukraine

    Active - Recruiting

  • Climb Investigative Site

    Kyiv,
    Ukraine

    Active - Recruiting

  • Climb Investigative Site #2380203

    Kyiv,
    Ukraine

    Active - Recruiting

  • Climb Investigative Site #380202

    Kyiv,
    Ukraine

    Active - Recruiting

  • Climb Investigative Site #380206

    Kyiv,
    Ukraine

    Site Not Available

  • Climb Investigative Site #2380203

    Kyiv 703448,
    Ukraine

    Active - Recruiting

  • Climb Investigative Site #380202

    Kyiv 703448,
    Ukraine

    Active - Recruiting

  • Climb Investigative Site #380206

    Kyiv 703448,
    Ukraine

    Active - Recruiting

  • Climb Investigative Site

    Lviv,
    Ukraine

    Active - Recruiting

  • Climb Investigative Site #380201

    Lviv,
    Ukraine

    Site Not Available

  • Climb Investigative Site #380201

    Lviv 702550,
    Ukraine

    Active - Recruiting

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