A Phase 1b/2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Budoprutug.
- Кому может быть актуально
- Состояния в реестре: Immune Thrombocytopenia (ITP), ITP, Biologics, Monoclonal. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Болгария, Греция, Сербия, Испания, Украина
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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)
Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат Budoprutug
Single IV dose of study product on Day 1 and Day 15
Первичные конечные точки
- Incidence of Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Up to week 48]
Вторичные конечные точки (10)
- Area Under the Curve (AUC) [Срок оценки: Up to week 48]
- Maximum Observed Plasma Concentration (Cmax) [Срок оценки: Up to week 48]
- Time to Maximum Observed Concentration (Tmax) [Срок оценки: Up to week 48]
- Terminal Half-Life (T1/2) [Срок оценки: Up to week 48]
- Apparent Clearance (CL/F) [Срок оценки: Up to week 48]
- Change from Baseline in CD20+ B-cell Count [Срок оценки: Up to week 48]
- Change in Platelet Count [Срок оценки: Up to week 48]
- Proportion of Participants with stable, partial or complete platelet response [Срок оценки: Up to week 48]
- Incidence of Anti-Drug Antibodies (ADAs) [Срок оценки: Up to week 48]
- Steroid Discontinuation Rate [Срок оценки: Up to week 48]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Украина · 6 центров
- 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
Греция · 4 центра
- Climb Bio Investigative Site #300204 — Athens
- Climb Bio Investigative Site #300203 — Chaïdári
- Climb Bio Investigative Site #300202 — Ioannina
- Climb Bio Investigative Site #300201 — Thessaloniki
Испания · 4 центра
- 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
Болгария · 3 центра
- Climb Bio Investigative Site #359202 — Plovdiv
- Climb Bio Investigative Site #359203 — Plovdiv
- Climb Bio Investigative Site #359201 — Sofia
Сербия · 3 центра
- Climb Bio Investigative Site #381201 — Belgrade
- Climb Bio Investigative Site #381202 — Belgrade
- Climb Bio Investigative Site #381203 — Novi Sad
Идентификаторы
NCT: NCT07043946 · TNT119-ITP-201