2024-519745-30-00撤回2 期
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)
Climb Bio Inc.5 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2025年6月23日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 6
- 试验地点
- 5
- 主要终点
- 1. Incidence, relatedness, severity, and duration of treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs).
研究概览
简要总结
To evaluate the safety and tolerability of ascending doses of budoprutug in subjects with ITP.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Part 2 - Long-Term Follow-up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Aged > 18 years at the time of informed 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 × upper limit of normal (ULN), prothrombin time < 1.5 × ULN, total bilirubin < 1.5 × ULN unless due to Gilbert’s syndrome, or an international normalized ratio < 1.5 at screening.
- •Adequate hematologic, hepatic, and renal function
- •If being treated with corticosteroids or thrombopoietin (TPO) agonists, subjects must be on a stable dose (< 20% change in dose over the 14 days prior to the first dose of study drug). Corticosteroid treatment should not be > 1 mg/kg methylprednisolone (or equivalent) for 2 weeks prior to the first dose of study drug.
- •Diagnosed with primary ITP
排除标准
- •CD19+ B-cell count < 80 cells/μL at Screening or < 40 cells/μL if B-cell depleting treatment was received within 24 weeks to 2 years prior to Screening.
- •Diagnosis of paroxysmal nocturnal hemoglobinuria, Evan’s Syndrome, or any other bleeding disorder that could confound results and impact patient safety.
- •Prior treatment with rituximab or other B-cell depleting agents within 24 weeks prior to the first dose of study drug or plan to receive B-cell depleting agents during the study.
- •Current or planned treatment with any chronic anticoagulants or platelet aggregation-inhibiting drugs such as aspirin, nonsteroidal anti-inflammatory drugs, or thienopyridines within 14 days of planned dosing through the end of follow-up. Symptom-based intermittent dosing of nonsteroidal anti-inflammatory drugs is permitted.
- •Prior treatment with immunosuppressants (other than corticosteroids) within 30 days or 5 times the elimination half-life (whichever is longer) of the Screening Visit (e.g., calcineurin inhibitors, mycophenolate mofetil, azathioprine), or alkylating agents within 180 days of the Screening Visit.
- •Active or uncontrolled infection at the time of informed consent or study drug initiation.
- •Recent hospitalization for any reason within 14 days prior to Screening, unless approved by the Medical Monitor.
- •Receipt of a live vaccine within 28 days prior to the first dose of study drug or during the study. All other vaccines must be completed within 21 days prior to the first dose of study drug.
- •Secondary cause of ITP (e.g., malignancy, hepatitis B or C, HIV, or other autoimmune diseases [e.g., thyroiditis], or drug-induced ITP).
结局指标
主要结局
1. Incidence, relatedness, severity, and duration of treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs).
1. Incidence, relatedness, severity, and duration of treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs).
次要结局
- 1. Budoprutug PK parameters (including area under the concentration-time curve, time to maximum observed concentration, terminal half-life, apparent clearance, and volume of distribution).
- 2. The change from baseline in absolute peripheral cluster of differentiation (CD)20+ B-cell count.
- 3. The change in platelet count observed with budoprutug over time in subjects with ITP.
- 4. The percentage of subjects with ITP who achieve a stable, partial, and complete response by Week 12. Note: A stable, partial, and complete response is defined as a platelet count ≥ 30,000/μL, ≥ 50,000/μL, or ≥ 100,000/μL, respectively, on at least 2 occasions at least 7 days apart within a 30-day time frame.
- 5. The change in serum IgG, IgM, and IgA from baseline over time.
- 6. The incidence of subjects who develop ADAs at any time after study drug administration.
- 7. The percentage of subjects on a steroid at baseline who are able to stop steroid treatment.
研究者
Janaki Subramanyam
Scientific
Climb Bio Inc.
研究点 (5)
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