A Phase 1b/2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Budoprutug.
- Who it may be relevant to
- Registry conditions: Immune Thrombocytopenia (ITP), ITP, Biologics, Monoclonal. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bulgaria, Greece, Serbia, Spain, Ukraine
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Detailed 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.
Interventions
- Drug Budoprutug
Single IV dose of study product on Day 1 and Day 15
Primary outcome measures
- Incidence of Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to week 48]
Secondary outcome measures (10)
- Area Under the Curve (AUC) [Time frame: Up to week 48]
- Maximum Observed Plasma Concentration (Cmax) [Time frame: Up to week 48]
- Time to Maximum Observed Concentration (Tmax) [Time frame: Up to week 48]
- Terminal Half-Life (T1/2) [Time frame: Up to week 48]
- Apparent Clearance (CL/F) [Time frame: Up to week 48]
- Change from Baseline in CD20+ B-cell Count [Time frame: Up to week 48]
- Change in Platelet Count [Time frame: Up to week 48]
- Proportion of Participants with stable, partial or complete platelet response [Time frame: Up to week 48]
- Incidence of Anti-Drug Antibodies (ADAs) [Time frame: Up to week 48]
- Steroid Discontinuation Rate [Time frame: Up to week 48]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Diagnosis of paroxysmal nocturnal hemoglobinuria, Evan's Syndrome, or other bleeding disorders affecting safety or data integrity.
- 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.
- Active, chronic, or latent infections including hepatitis B/C or HIV.
- Active TB or high TB risk.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Ukraine · 6 centers
- Climb Bio Investigative Site #380208 — Cherkasy
- Climb Investigative Site #380204 — Ivano-Frankivsk
- Climb Investigative Site #2380203 — Kyiv
- Climb Investigative Site #380202 — Kyiv
- Climb Investigative Site #380206 — Kyiv
- Climb Investigative Site #380201 — Lviv
Greece · 4 centers
- Climb Bio Investigative Site #300204 — Athens
- Climb Bio Investigative Site #300203 — Chaïdári
- Climb Bio Investigative Site #300202 — Ioannina
- Climb Bio Investigative Site #300201 — Thessaloniki
Spain · 4 centers
- Climb Bio Investigative Site #340206 — Burgos
- Climb Bio Investigative Site #340204 — Madrid
- Climb Bio Investigative Site #340202 — San Pedro
- Climb Bio Investigative Site #340203 — Valencia
Bulgaria · 3 centers
- Climb Bio Investigative Site #359202 — Plovdiv
- Climb Bio Investigative Site #359203 — Plovdiv
- Climb Bio Investigative Site #359201 — Sofia
Serbia · 3 centers
- Climb Bio Investigative Site #381201 — Belgrade
- Climb Bio Investigative Site #381202 — Belgrade
- Climb Bio Investigative Site #381203 — Novi Sad
Identifiers
NCT: NCT07043946 · TNT119-ITP-201