A Phase 1b/2a Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
2026年8月4日 更新者：Climb Bio, Inc.
A Phase 1b/2a Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Budoprutug (TNT119) in Adult Subjects With Systemic Lupus Erythematosus (SLE)
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 study will evaluate budoprutug in ascending dose cohorts of patients aged 18 years and above with active, seropositive SLE and inadequate response to standard therapy.
The study will also assess the pharmacokinetics, pharmacodynamics and early indications of efficacy of budoprutug in SLE, where pharmacodynamics will be evaluated as the change in the number of B cells and immunoglobulins (antibodies) in the blood over time.
Budoprutug will be administered as two (2) IV infusions 14 days apart in ascending dose cohorts.
研究概览
研究类型
介入性
注册 (估计的)
30
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Climb Bio Study Director
- 电话号码：+1 8668572596
- 邮箱：clinicaltrials@climbbio.com
学习地点
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Beijing、中国
- 招聘中
- Peking University People's Hospital
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接触：
- Climb Bio Investigative Site 1
- 邮箱：clinicaltrials@climbbio.com
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Sichuan
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Mianyang、Sichuan、中国、621000
- 主动，不招人
- Mianyang Central Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Aged 18 to 65 years at the time of consent.
- Diagnosis of SLE according to the 2019 European League Against. Rheumatism and the American College of Rheumatology (ACR) classification criteria.
- Active, seropositive disease, with SLEDAI 2K >=6 at screening
- Inadequate response to at least one therapeutic intervention
Exclusion Criteria:
- Active neuropsychiatric SLE.
- Active lupus nephritis type III or IV that is expected to require induction therapy during the study or recently treated with induction therapy within 12 weeks.
- Prior diagnosis of, or fulfills diagnostic criteria for, other autoimmune or inflammatory disease that may confound clinical assessments or increase subject risk in the study
- Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Cohort 1: Dose Level A
Single IV dose at Day 1 and Day 15
|
第1天和第15天的单静脉研究产品剂量
其他名称：
|
|
实验性的：Cohort 2: Dose Level B
Single IV dose at Day 1 and Day 15
|
第1天和第15天的单静脉研究产品剂量
其他名称：
|
|
实验性的：Cohort 3: Dose Level C
Single IV dose at Day 1 and Day 15
|
第1天和第15天的单静脉研究产品剂量
其他名称：
|
|
实验性的：Dose Expansion Cohort
Single IV dose at Day 1 and Day 15
|
第1天和第15天的单静脉研究产品剂量
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events (TEAEs)
大体时间：Up to week 28
|
Number of participants experiencing TEAEs, graded per NCI CTCAE v6.0.
|
Up to week 28
|
|
Incidence of Clinical Laboratory Abnormalities
大体时间：Up to week 28
|
Number of participants with clinically significant laboratory abnomalities.
|
Up to week 28
|
|
Incidence of dose-limiting toxicities (DLTs)
大体时间：up to 28 weeks
|
Number of incidences of dose-limiting toxicities (DLTs)
|
up to 28 weeks
|
|
Change from Baseline in Systolic Blood Pressure
大体时间：Up to week 28
|
Mean change from baseline in diastolic blood pressure (mmHg).
|
Up to week 28
|
|
Change from Baseline in Diastolic Blood Pressure
大体时间：up to 28 weeks
|
Mean change from baseline in systolic blood pressure (mmHg).
|
up to 28 weeks
|
|
Change from Baseline in Heart Rate
大体时间：up to 28 weeks
|
Mean change from baseline in heart rate (bpm).
|
up to 28 weeks
|
|
Change from Baseline in Respiratory Rate
大体时间：up to 28 weeks
|
Mean change from baseline in respiratory rate
|
up to 28 weeks
|
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Change from Baseline in Body Temperature
大体时间：up to 28 weeks
|
Mean change from baseline in body temperature (°C)
|
up to 28 weeks
|
|
Change from Baseline in PR Interval
大体时间：up to 28 weeks
|
Mean change from baseline in PR interval (ms)
|
up to 28 weeks
|
|
Change from Baseline in QRS Duration
大体时间：up to 28 weeks
|
Mean change from baseline in QRS duration (ms)
|
up to 28 weeks
|
|
Change from Baseline in QT Interval
大体时间：up to 28 weeks
|
Mean change from baseline in QT interval (ms)
|
up to 28 weeks
|
|
Change from Baseline in QTc Interval
大体时间：up to 28 weeks
|
Mean change from baseline in corrected QT interval (QTc)
|
up to 28 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Area Under the Curve (AUC)
大体时间：Up to week 28
|
Measurement of the area under the drug concentration-time curve
|
Up to week 28
|
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Terminal Half-Life (T1/2)
大体时间：Up to week 28
|
Measurement of the terminal half-life in days
|
Up to week 28
|
|
Incidence of Anti-Drug Antibodies (ADAs)
大体时间：Up to week 28
|
Number of participants with detectable ADAs.
|
Up to week 28
|
|
ADA Titer Over Time
大体时间：Up to week 28
|
Measurement of ADA titer over time
|
Up to week 28
|
|
Change from Baseline in CD20+ B-cell Count
大体时间：Up to week 28
|
Change in absolute peripheral B-cell count
|
Up to week 28
|
|
Change from Baseline in SLEDAI-2K Score
大体时间：up to 28 weeks
|
Measurement of change in SLEDAI-2K score from baseline
|
up to 28 weeks
|
|
Change from Baseline in Urine Protein Creatinine Ratio (UPCR)
大体时间：up to 28 weeks
|
Measurement of change in UPCR from baseline
|
up to 28 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Study Director、Climb Bio, Inc.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月30日
初级完成 (估计的)
2027年9月1日
研究完成 (估计的)
2027年9月1日
研究注册日期
首次提交
2026年4月27日
首先提交符合 QC 标准的
2026年4月27日
首次发布 (实际的)
2026年5月4日
研究记录更新
最后更新发布 (实际的)
2026年8月6日
上次提交的符合 QC 标准的更新
2026年8月4日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.