Actively Recruiting
Phase 1b/2a Open-Label Study to Evaluate Budoprutug (TNT119) for Immune Thrombocytopenia (ITP) Assessing Safety, Tolerability, Pharmacokinetics, and Preliminary Effectiveness
Led by Climb Bio, Inc. · Updated on 2026-03-27
24
Participants Needed
20
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating budoprutug, a humanized monoclonal antibody targeting CD19, in adults with immune thrombocytopenia (ITP), a condition characterized by low platelet counts. This Phase 1b/2a open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical effects of budoprutug in patients with platelet counts below 30,000/µL despite prior treatment attempts. The study is sponsored by Climb Bio, Inc. Participants will receive budoprutug as two intravenous infusions administered 14 days apart. The study includes sequential cohorts with escalating doses, followed by a dose expansion group. Each participant receives a single IV dose on Day 1 and another on Day 15. The trial monitors the effects of budoprutug on platelet counts and CD20+ B-cell levels, among other factors. Throughout the study, participants will be closely monitored up to 48 weeks for treatment-related side effects, blood levels of the drug, immune cell changes, platelet responses, and the development of anti-drug antibodies. Safety labs including coagulation tests and bilirubin levels will be assessed. The study does not include placebo groups and participation involves scheduled visits for infusions and follow-up evaluations to track both safety and preliminary clinical outcomes over nearly a year.
CONDITIONS
Brief Title
A Phase 1b/2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older at consent
- Platelet count below 30,000/µL confirmed twice 5 to 14 days apart despite prior treatment
- Partial thromboplastin time less than 1.5 times upper limit of normal
- Prothrombin time less than 1.5 times upper limit of normal
- Total bilirubin less than 1.5 times upper limit of normal unless due to Gilbert's syndrome
- International normalized ratio less than 1.5 at screening
You will not qualify if you...
- CD19+ B cell count below 80 cells/µL at screening, or below 40 cells/µL if prior B-cell therapy was within 24 weeks to 2 years
- Diagnosis of paroxysmal nocturnal hemoglobinuria, Evan's Syndrome, or other bleeding disorders affecting safety or data
- Prior B-cell depleting therapy within 24 weeks before first dose or planned during study
- Chronic use of anticoagulants or antiplatelet agents within 14 days before dosing through follow-up
- Immunosuppressants (excluding corticosteroids) within 30 days or five half-lives before screening; alkylating agents within 180 days
- Intravenous immunoglobulin treatment within 90 days before screening
- Active ITP treatment other than steroids or thrombopoietin agonists within 30 days before first dose unless approved
- Active, chronic, or latent infections including hepatitis B, C, or HIV
- Active tuberculosis or high tuberculosis risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive two intravenous infusions of Budoprutug, given 14 days apart, to evaluate safety, tolerability, and preliminary effectiveness.
2 infusion visits on Day 1 and Day 15
Duration - Up to 48 weeks
Participants are monitored for safety, pharmacokinetics, and platelet response for up to 48 weeks after treatment.
Regular follow-up visits during the 48 weeks
Trial Site Locations
Total: 20 locations
1
Climb Bio Investigative Site #359202
Plovdiv, Bulgaria, 4002
Actively Recruiting
2
Climb Bio Investigative Site #359203
Plovdiv, Bulgaria, 4003
Actively Recruiting
3
Climb Bio Investigative Site #359201
Sofia, Bulgaria, 1797
Actively Recruiting
4
Climb Bio Investigative Site #300204
Athens, Attica, Greece, 11527
Actively Recruiting
5
Climb Bio Investigative Site #300203
Chaïdári, Attica, Greece, 12462
Actively Recruiting
6
Climb Bio Investigative Site #300202
Ioannina, Greece, 45500
Actively Recruiting
7
Climb Bio Investigative Site #300201
Thessaloniki, Greece, 57010
Actively Recruiting
8
Climb Bio Investigative Site #381201
Belgrade, Serbia
Actively Recruiting
9
Climb Bio Investigative Site #381202
Belgrade, Serbia
Actively Recruiting
10
Climb Bio Investigative Site #381203
Novi Sad, Serbia
Actively Recruiting
11
Climb Bio Investigative Site #340206
Burgos, Spain, 9006
Not Yet Recruiting
12
Climb Bio Investigative Site #340204
Madrid, Spain, 28041
Actively Recruiting
13
Climb Bio Investigative Site #340202
San Pedro, Spain
Actively Recruiting
14
Climb Bio Investigative Site #340203
Valencia, Spain, 46010
Actively Recruiting
15
Climb Bio Investigative Site #380208
Cherkasy, Ukraine
Not Yet Recruiting
16
Climb Investigative Site #380204
Ivano-Frankivsk, Ukraine
Actively Recruiting
17
Climb Investigative Site #2380203
Kyiv, Ukraine
Actively Recruiting
18
Climb Investigative Site #380202
Kyiv, Ukraine
Actively Recruiting
19
Climb Investigative Site #380206
Kyiv, Ukraine
Actively Recruiting
20
Climb Investigative Site #380201
Lviv, Ukraine
Actively Recruiting
Research Team
C
Climb Bio Study Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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