A Study to Test CRT-402 in Refractory Autoimmune Disease
2026年8月19日 更新者：Myeloid Therapeutics
A Phase 1/2 Dose Escalation and Expansion Study of CRT-402, an In Vivo CD19 Targeted CAR-T Therapy, in Refractory Autoimmune Disease
Patients with refractory autoimmune diseases often have limited treatment options and ongoing disease activity despite standard therapies.
CRT-402 is an in vivo Cluster of differentiation 19 (CD19)-targeted CAR-T cell therapy designed to deplete CD19-positive B cells and promote immune system reset.
This study evaluates the safety, tolerability, preliminary efficacy, pharmacodynamics (PD), and pharmacokinetics (PK) of CRT-402 in participants with active refractory systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and idiopathic inflammatory myopathies (IIM).
研究概览
详细说明
This is a multicenter, open-label, Phase 1/2, first-in-human, dose escalation and expansion study designed to assess the safety and tolerability, as well as define the recommended Phase 2 dose (RP2D) of CRT-402 in participants with refractory autoimmune disease.
研究类型
介入性
注册 (估计的)
34
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：Clinical Department
- 电话号码：+1 617 465 1022
- 邮箱：CRT402-clinical@createmedicines.com
学习地点
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Western Australia
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Nedlands、Western Australia、澳大利亚、6009
- Linear Advanced Clinical Trial Centre, Ground Floor, B Block, Queen Elizabeth II Medical Centre, Hospital Avenue
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接触：
- Prof. Merrilee Needham
- 电话号码：+61 8 6382 5100
- 邮箱：actcstartup@linear.org.au
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首席研究员：
- Merrilee Needham
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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:
- Age 18 years or older.
- Diagnosis of active, refractory systemic lupus erythematosus, systemic sclerosis, or idiopathic inflammatory myopathy meeting established classification criteria, with inadequate response or intolerance to standard therapy.
- Adequate renal, hepatic, cardiac, and pulmonary function per protocol-defined criteria.
- Participants of reproductive potential must agree to use protocol-specified contraception during the study and for a defined period after dosing.
- Females of childbearing potential must have a negative pregnancy test before treatment.
- Must be willing and able to attend study visits and follow all study requirements.
Exclusion Criteria:
- Clinical suitability for a less burdensome and/or approved therapeutic approach, as judged by the Investigator,
- Any medical condition or laboratory abnormality that, in the Investigator's judgment, would place the participant at unacceptable risk or confound interpretation of study data,
- Prior Cluster of differentiation 19 (CD19)-directed, cell, or gene therapy,
- History of bone marrow/ hematopoietic stem cell or solid organ transplantation,
- Active or inadequately treated infection, including Human immunodeficiency (HIV), hepatitis B or C, or tuberculosis,
- Pregnancy or lactation.
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：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：CRT-402
Participants will receive CRT-402 by intravenous infusion.
Dose escalation will proceed according to protocol-defined safety criteria.
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CRT-402 administered by intravenous infusion.
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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 |
|---|---|---|
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Incidence and severity of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), and dose-limiting toxicities (DLTs).
大体时间：Up to 52 weeks
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Adverse events (AEs) are any new or worsening medical problems that occur after starting the study treatment.
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Up to 52 weeks
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Incidence and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
大体时间：Up to 52 weeks
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cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome ICANS will be graded using standard consensus criteria.
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Up to 52 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Assess emergence of anti-drug antibodies (ADAs)
大体时间：Up to 52 weeks
|
Serum for anti-drug antibody analysis will be collected at designated visits indicated in the Schedule of Assessments (SOA).
Samples will be collected using standard site practices.
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Up to 52 weeks
|
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Pharmacokinetic parameter: Maximum observed plasma concentration (Cmax)
大体时间：Day 1 through Day 22
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Day 1 through Day 22
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Pharmacokinetic parameter: Area under the curve (AUC)
大体时间：Day 1 through Day 22
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Day 1 through Day 22
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Pharmacokinetic parameter: Time to Maximum Concentration (tmax)
大体时间：Day 1 through Day 22
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Day 1 through Day 22
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|
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Pharmacokinetic parameter: Plasma clearance (CL)
大体时间：Day 1 through Day 22
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Day 1 through Day 22
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Pharmacokinetic parameter: Volume of distribution (Vd)
大体时间：Day 1 through Day 22
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Day 1 through Day 22
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Pharmacokinetic parameter: Mean Residence Time (MRT)
大体时间：Day 1 through Day 22
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Day 1 through Day 22
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Pharmacokinetic parameter: Apparent terminal half-life (t1/2)
大体时间：Day 1 through Day 22
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Day 1 through Day 22
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Pharmacokinetic parameter: Terminal elimination rate constant (λz).
大体时间：Day 1 through Day 22
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Day 1 through Day 22
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Overall Response Rate (ORR), measured by disease-specific composite response criteria.
大体时间：Week 24
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Week 24
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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。
合作者
调查人员
- 研究主任：Adam Raff, MD, PhD、SVP Clinical Development, CREATE Medicines
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 (估计的)
2026年8月24日
初级完成 (估计的)
2028年12月1日
研究完成 (估计的)
2029年8月1日
研究注册日期
首次提交
2026年8月6日
首先提交符合 QC 标准的
2026年8月19日
首次发布 (实际的)
2026年8月21日
研究记录更新
最后更新发布 (实际的)
2026年8月21日
上次提交的符合 QC 标准的更新
2026年8月19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.